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idK170974_s0_e2000 | K170974.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170974 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: BD Biosciences BD FACSLyric Flow Cytometer (3−1, 4−2, 4−2−2 and 4−3−3 optical configurations) with BD FACSuite Clinical Software D. Type of Test or Tests Perform... |
idK170974_s0_e2000 | K170974.txt | product code | OYE, flow cytometric reagents and accessories | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170974 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: BD Biosciences BD FACSLyric Flow Cytometer (3−1, 4−2, 4−2−2 and 4−3−3 optical configurations) with BD FACSuite Clinical Software D. Type of Test or Tests Perform... |
idK170974_s0_e2000 | K170974.txt | panel | Hematology (81) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170974 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: BD Biosciences BD FACSLyric Flow Cytometer (3−1, 4−2, 4−2−2 and 4−3−3 optical configurations) with BD FACSuite Clinical Software D. Type of Test or Tests Perfor... |
idK170974_s0_e2000 | K170974.txt | applicant | BD Biosciences | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170974 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: BD Biosciences BD FACSLyric Flow Cytometer (3−1, 4−2, 4−2−2 and 4−3−3 optical configurations) with BD FACSuite Clinical Software D. Type of Test or Tests Perform... |
idK170974_s0_e2000 | K170974.txt | regulation section | 21 CFR §864.5220, Automated Differential Cell Counter | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170974 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: BD Biosciences BD FACSLyric Flow Cytometer (3−1, 4−2, 4−2−2 and 4−3−3 optical configurations) with BD FACSuite Clinical Software D. Type of Test or Tests Performe... |
idK170974_s8000_e10000 | K170974.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | 44 0.93 0.0 0.22 0.47 1.06 Normal Average CD3+ % 76.74 0.68 0.07 0.34 0.10 0.77 CD3+% Tube A 76.64 0.85 0.12 0.31 0.0 0.91 CD3+% Tube B 76.84 1.00 0.0 0.23 0.22 1.05 CD4+ % 51.67 1.39 0.0 0.74 0.0 1.58 CD8+ % 23.23 0.83 0.0 0.0 0.19 0.85 CD19+% 12.... |
idK170974_s8000_e10000 | K170974.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | 19.44 0.93 0.0 0.22 0.47 1.06 Normal Average CD3+ % 76.74 0.68 0.07 0.34 0.10 0.77 CD3+% Tube A 76.64 0.85 0.12 0.31 0.0 0.91 CD3+% Tube B 76.84 1.00 0.0 0.23 0.22 1.05 CD4+ % 51.67 1.39 0.0 0.74 0.0 1.58 CD8+ % 23.23 0.83 0.0 0.0 0.19 0.85 CD19+%... |
idK160585_s0_e2000 | K160585.txt | measurand | WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%) | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Series an... |
idK160585_s0_e2000 | K160585.txt | type of test | Quantitative | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Serie... |
idK160585_s0_e2000 | K160585.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Seri... |
idK160585_s0_e2000 | K160585.txt | product code | KRX, Calibrator for cell indices | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Seri... |
idK160585_s0_e2000 | K160585.txt | panel | Hematology (81) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Ser... |
idK160585_s0_e2000 | K160585.txt | predicate device name | XN CAL | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Series an... |
idK160585_s0_e2000 | K160585.txt | applicant | Streck, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Seri... |
idK160585_s0_e2000 | K160585.txt | proprietary and established names | XN CAL | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Series analyze... |
idK160585_s0_e2000 | K160585.txt | regulation section | 21 CFR § 864.8150, Calibrator for cell indices | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Serie... |
idK160585_s2000_e4000 | K160585.txt | proposed labeling | The provided labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10. | ... |
idK160585_s2000_e4000 | K160585.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK180607_s0_e2000 | K180607.txt | purpose for submission | New device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprieta... |
idK180607_s0_e2000 | K180607.txt | measurand | Steroid 21-Hydroxylase Antibody (21-OHAb) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprieta... |
idK180607_s0_e2000 | K180607.txt | type of test | Manual�enzyme-linked� immunosorbent� assay,�qualitative | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Propriet... |
idK180607_s0_e2000 | K180607.txt | classification | I | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprie... |
idK180607_s0_e2000 | K180607.txt | panel | Immunology� (82)� | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Propri... |
idK180607_s0_e2000 | K180607.txt | intended use | The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as aut... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Propriet... |
idK180607_s0_e2000 | K180607.txt | predicate device name | KRONUS 21-OHAb RIA Assay Kit | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprieta... |
idK180607_s0_e2000 | K180607.txt | applicant | KRONUS�Market�Development� Associates,�INC.� | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprie... |
idK180607_s0_e2000 | K180607.txt | proprietary and established names | KRONUS�Steroid� 21-Hydroxylase� Autoantibody� (21-OHAb)�ELISA�Kit | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprietary and... |
idK180607_s8000_e10000 | K180607.txt | proposed labeling | The�labeling� is�sufficient� and�it�satisfies�the�requirements�of�21�CFR�Part�809.10.� | ... |
idK180209_s0_e2000 | K180209.txt | purpose for submission | New Device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Establish... |
idK180209_s0_e2000 | K180209.txt | measurand | 1,5-Anhydroglucitol (1,5-AG) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Establish... |
idK180209_s0_e2000 | K180209.txt | type of test | Quantitative, colorometric, pyranose oxidase (PROD) | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Establis... |
idK180209_s0_e2000 | K180209.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Establi... |
idK180209_s0_e2000 | K180209.txt | product code | NOZ; Assay, 1,5-Anhydroglucitol | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Establi... |
idK180209_s0_e2000 | K180209.txt | panel | Hematology (81) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Establ... |
idK180209_s0_e2000 | K180209.txt | intended use | See indications for use below. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Establis... |
idK180209_s0_e2000 | K180209.txt | predicate device name | GlycoMark | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Establish... |
idK180209_s0_e2000 | K180209.txt | applicant | Diazyme Laboratories Inc. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Establi... |
idK180209_s0_e2000 | K180209.txt | proprietary and established names | Diazyme 1,5-AG Assay | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Established Nam... |
idK180209_s0_e2000 | K180209.txt | regulation section | 21 CFR 864.7470; Glycosylated hemoglobin assay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Establis... |
idK180209_s2000_e4000 | K180209.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. | ... |
idK180209_s2000_e4000 | K180209.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK190223_s0_e2000 | K190223.txt | purpose for submission | To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated... |
idK190223_s0_e2000 | K190223.txt | measurand | Nucleic acids from inactivated Chlamydia trachomatis and Neisseria gonorrhoeae (positive control) and from human epithelial cells (negative control). | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated... |
idK190223_s0_e2000 | K190223.txt | type of test | The Cepheid Xpert CT/NG Control Panel is an external assayed quality control material (positive and negative) designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in genitourinary specimens when used w... | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactiv... |
idK190223_s0_e2000 | K190223.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inacti... |
idK190223_s0_e2000 | K190223.txt | panel | (83) Microbiology | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inact... |
idK190223_s0_e2000 | K190223.txt | predicate device name | Cepheid Xpert GBS LB Control Panel | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated... |
idK190223_s0_e2000 | K190223.txt | applicant | Microbiologics, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inacti... |
idK190223_s0_e2000 | K190223.txt | proprietary and established names | Cepheid Xpert CT/NG Control Panel | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated Chla... |
idK190223_s0_e2000 | K190223.txt | regulation section | 21 CFR 866.3920, Assayed quality control material for clinical microbiology assays | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactiv... |
idK190223_s4000_e6000 | K190223.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | ... |
idK190223_s4000_e6000 | K190223.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision | ... |
idK162042_s0_e2000 | K162042.txt | purpose for submission | New device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant: ... |
idK162042_s0_e2000 | K162042.txt | measurand | Plasma glucose from central venous catheter blood draw | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant: ... |
idK162042_s0_e2000 | K162042.txt | type of test | Quantitative, mid-infrared (MIR) spectrophotometric assay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant:... |
idK162042_s0_e2000 | K162042.txt | intended use | See Indication(s) for use below. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant:... |
idK162042_s0_e2000 | K162042.txt | predicate device name | VIA Medical Corp Pump/Blood Chemistry Monitor | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant: ... |
idK162042_s0_e2000 | K162042.txt | applicant | OptiScan Biomedical Corporation | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant... |
idK162042_s0_e2000 | K162042.txt | proprietary and established names | OptiScanner 5000 Glucose Monitoring System | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant: OptiSc... |
idK162042_s8000_e10000 | K162042.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK162042_s8000_e10000 | K162042.txt | conclusion | Due to an administrative error, additional conclusions were erroneously included and have now been removed. The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK192815_s0_e2000 | K192815.txt | purpose for submission | The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared produc... | 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly inte... |
idK192815_s0_e2000 | K192815.txt | measurand | Procalcitonin (PCT) | 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly inte... |
idK192815_s0_e2000 | K192815.txt | type of test | Quantitative, Electrochemiluminescence Immunoassay | Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly... |
idK192815_s0_e2000 | K192815.txt | classification | Class II | - Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significant... |
idK192815_s0_e2000 | K192815.txt | product code | PRI | - Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significant... |
idK192815_s0_e2000 | K192815.txt | panel | MI - Microbiology | 15 - Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significa... |
idK192815_s0_e2000 | K192815.txt | intended use | See Indications for Use below. | Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly... |
idK192815_s0_e2000 | K192815.txt | predicate device name | Elecsys BRAHMS PCT | 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly inte... |
idK192815_s0_e2000 | K192815.txt | applicant | Roche Diagnostics | - Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significant... |
idK192815_s0_e2000 | K192815.txt | proprietary and established names | Elecsys BRAHMS PCT | 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere... |
idK192815_s0_e2000 | K192815.txt | regulation section | 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis | Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly... |
idK192815_s8000_e10000 | K192815.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | ... |
idK192815_s8000_e10000 | K192815.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK183415_s0_e2000 | K183415.txt | purpose for submission | To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test (AST) Systems. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Co... |
idK183415_s0_e2000 | K183415.txt | measurand | Imipenem 0.25 – 16 µg/mL | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Co... |
idK183415_s0_e2000 | K183415.txt | type of test | Automated quantitative antimicrobial susceptibility (AST) | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 C... |
idK183415_s0_e2000 | K183415.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 ... |
idK183415_s0_e2000 | K183415.txt | panel | 83 Microbiology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2... |
idK183415_s0_e2000 | K183415.txt | intended use | The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 C... |
idK183415_s0_e2000 | K183415.txt | predicate device name | VITEK 2 AST-GN Amikacin | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Co... |
idK183415_s0_e2000 | K183415.txt | applicant | bioMérieux, Inc. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 ... |
idK183415_s0_e2000 | K183415.txt | proprietary and established names | VITEK 2 AST-Gram Negative Imipenem (≤0.25 - ≥16 µg/mL) | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact ... |
idK183415_s0_e2000 | K183415.txt | regulation section | 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 C... |
idK183415_s6000_e8000 | K183415.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device | ... |
idK183415_s6000_e8000 | K183415.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK151923_s0_e2000 | K151923.txt | purpose for submission | To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast card ... |
idK151923_s0_e2000 | K151923.txt | type of test | Automated quantitative or qualitative antifungal susceptibility test of Candida species to Micafungin | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast c... |
idK151923_s0_e2000 | K151923.txt | classification | II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast ... |
idK151923_s0_e2000 | K151923.txt | panel | 83 Microbiology | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast... |
idK151923_s0_e2000 | K151923.txt | intended use | The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. an... | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast c... |
idK151923_s0_e2000 | K151923.txt | predicate device name | VITEK® 2 AST-YST Flucytosine | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast card ... |
idK151923_s0_e2000 | K151923.txt | applicant | bioMérieux, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast ... |
idK151923_s0_e2000 | K151923.txt | proprietary and established names | VITEK® 2 AST-Yeast Micafungin (0.06 - 8 µg/mL) | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast card conta... |
idK151923_s0_e2000 | K151923.txt | regulation section | 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast c... |
idK151923_s4000_e6000 | K151923.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK151923_s4000_e6000 | K151923.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK171742_s0_e2000 | K171742.txt | purpose for submission | New device on two previously cleared instruments | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K171742 B. Purpose for Submission: New device on two previously cleared instruments C. Measurand: Kappa (κ) Free Light Chain (FLC) Lambda (λ) Free Light Chain (FLC) D. Type of Test: Nephelometry, quantitative E. Applicant: Siemens Healthcare Diagn... |
idK171742_s0_e2000 | K171742.txt | type of test | Nephelometry, quantitative | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K171742 B. Purpose for Submission: New device on two previously cleared instruments C. Measurand: Kappa (κ) Free Light Chain (FLC) Lambda (λ) Free Light Chain (FLC) D. Type of Test: Nephelometry, quantitative E. Applicant: Siemens Healthcare D... |
idK171742_s0_e2000 | K171742.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K171742 B. Purpose for Submission: New device on two previously cleared instruments C. Measurand: Kappa (κ) Free Light Chain (FLC) Lambda (λ) Free Light Chain (FLC) D. Type of Test: Nephelometry, quantitative E. Applicant: Siemens Healthcare ... |
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