doc_id stringclasses 201
values | file_name stringclasses 100
values | key stringclasses 15
values | value stringlengths 1 1.66k | text stringlengths 2.2k 9.79k |
|---|---|---|---|---|
idK153137_s0_e2000 | K153137.txt | purpose for submission | Clearance of a new device | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Es... |
idK153137_s0_e2000 | K153137.txt | measurand | Anti-PF4/Heparin Total Antibodies | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Es... |
idK153137_s0_e2000 | K153137.txt | type of test | Automated, latex enhanced immuno-turbidimetric assay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary an... |
idK153137_s0_e2000 | K153137.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary a... |
idK153137_s0_e2000 | K153137.txt | panel | Hematology (81) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary ... |
idK153137_s0_e2000 | K153137.txt | predicate device name | Asserachrom HPIA Test kit from Diagnostica Stago | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Es... |
idK153137_s0_e2000 | K153137.txt | applicant | Instrumentation Laboratory (IL) Co. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary a... |
idK153137_s8000_e10000 | K153137.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK153137_s8000_e10000 | K153137.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK150041_s0_e2000 | K150041.txt | purpose for submission | Clearance of a new device | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietar... |
idK150041_s0_e2000 | K150041.txt | measurand | Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietar... |
idK150041_s0_e2000 | K150041.txt | type of test | Whole blood hemostasis | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Propri... |
idK150041_s0_e2000 | K150041.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Propr... |
idK150041_s0_e2000 | K150041.txt | panel | Hematology (81) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Prop... |
idK150041_s0_e2000 | K150041.txt | predicate device name | Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietar... |
idK150041_s0_e2000 | K150041.txt | applicant | Coramed Technologies, LLC | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Propr... |
idK150041_s8000_e10000 | K150041.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK150041_s8000_e10000 | K150041.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK143329_s0_e2000 | K143329.txt | purpose for submission | To obtain clearance for a new device, Amplivue® Trichomonas Assay | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-depend... |
idK143329_s0_e2000 | K143329.txt | measurand | A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-depend... |
idK143329_s0_e2000 | K143329.txt | type of test | Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-de... |
idK143329_s0_e2000 | K143329.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-d... |
idK143329_s0_e2000 | K143329.txt | product code | OUY - Trichomonas vaginalis nucleic acid amplification test system | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-d... |
idK143329_s0_e2000 | K143329.txt | panel | 83 - Microbiology | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-... |
idK143329_s0_e2000 | K143329.txt | intended use | The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females... | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-de... |
idK143329_s0_e2000 | K143329.txt | predicate device name | APTIMA Trichomonas vaginalis Assay (PANTHER® System) | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-depend... |
idK143329_s0_e2000 | K143329.txt | applicant | Quidel Corporation | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-d... |
idK143329_s0_e2000 | K143329.txt | proprietary and established names | Amplivue® Trichomonas Assay | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent A... |
idK143329_s0_e2000 | K143329.txt | regulation section | 21 CFR 866.3860 | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-de... |
idK143329_s6000_e8000 | K143329.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK143329_s6000_e8000 | K143329.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK181525_s0_e2000 | K181525.txt | purpose for submission | New Device | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANC... |
idK181525_s0_e2000 | K181525.txt | measurand | Free Protein S Antigen (%) | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANC... |
idK181525_s0_e2000 | K181525.txt | type of test | Quantitative immunoturbidimetric assay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNO... |
idK181525_s0_e2000 | K181525.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INN... |
idK181525_s0_e2000 | K181525.txt | product code | GGP, Test, qualitative and quanititative factor deficiency | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INN... |
idK181525_s0_e2000 | K181525.txt | panel | Hematology (81) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: IN... |
idK181525_s0_e2000 | K181525.txt | intended use | For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has... | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNO... |
idK181525_s0_e2000 | K181525.txt | predicate device name | STA-Liatest Free Protein S | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANC... |
idK181525_s0_e2000 | K181525.txt | applicant | Siemens Healthcare Diagnostics Product GmbH | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INN... |
idK181525_s0_e2000 | K181525.txt | proprietary and established names | INNOVANCE® Free PS Ag | IAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANCE® Fr... |
idK181525_s0_e2000 | K181525.txt | regulation section | 21 CFR 864.7290, Factor deficiency test | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNO... |
idK181525_s6000_e8000 | K181525.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 809.10. | ... |
idK181525_s6000_e8000 | K181525.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK170464_s0_e2000 | K170464.txt | measurand | Fresh capillary whole blood glucose from the fingertip | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton label... |
idK170464_s0_e2000 | K170464.txt | type of test | Quantitative, amperometric assay (Glucose Oxidase) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labe... |
idK170464_s0_e2000 | K170464.txt | classification | Class II | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton lab... |
idK170464_s0_e2000 | K170464.txt | product code | NBW, System, Test, Blood Glucose, Over The Counter | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton lab... |
idK170464_s0_e2000 | K170464.txt | panel | Clinical Chemistry (75) | 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton ... |
idK170464_s0_e2000 | K170464.txt | intended use | See indication(s) for use below. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labe... |
idK170464_s0_e2000 | K170464.txt | predicate device name | StatStrip Xpress Blood Glucose Monitoring System | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton label... |
idK170464_s0_e2000 | K170464.txt | applicant | Nova Biomedical Corporation | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton lab... |
idK170464_s0_e2000 | K170464.txt | proprietary and established names | StatStrip Xpress Blood Glucose Monitoring System | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labeling, ... |
idK170464_s0_e2000 | K170464.txt | regulation section | 21 CFR 862.1345, Glucose test system | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labe... |
idK170464_s2000_e4000 | K170464.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK170464_s2000_e4000 | K170464.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK141689_s0_e2000 | K141689.txt | purpose for submission | New assay | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Protein I... |
idK141689_s0_e2000 | K141689.txt | measurand | C-reactive protein (CRP) | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Protein I... |
idK141689_s0_e2000 | K141689.txt | type of test | Quantitative | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Prote... |
idK141689_s0_e2000 | K141689.txt | panel | Clinical Chemistry | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Pro... |
idK141689_s0_e2000 | K141689.txt | intended use | See indication for use. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Prote... |
idK141689_s0_e2000 | K141689.txt | indications for use | FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack High Sensitivity C-Reactive Protein Immunoassay is intended for use with... | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Protein I... |
idK141689_s0_e2000 | K141689.txt | applicant | Qualigen, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Prot... |
idK141689_s4000_e6000 | K141689.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | of blank was determined from 80 replicate... |
idK141689_s4000_e6000 | K141689.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | the limit of blank was determined from 80... |
idK150168_s0_e2000 | K150168.txt | purpose for submission | New Device | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Flex® R... |
idK150168_s0_e2000 | K150168.txt | measurand | Tacrolimus | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Flex® R... |
idK150168_s0_e2000 | K150168.txt | type of test | Quantitative immunoassay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Fle... |
idK150168_s0_e2000 | K150168.txt | product code | MLM, JIT | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Fl... |
idK150168_s0_e2000 | K150168.txt | panel | Toxicology (91) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus F... |
idK150168_s0_e2000 | K150168.txt | intended use | See indications for use below. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Fle... |
idK150168_s0_e2000 | K150168.txt | predicate device name | ARCHITECT Tacrolimus Assay | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Flex® R... |
idK150168_s0_e2000 | K150168.txt | applicant | Siemens Healthcare Diagnostics, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Fl... |
idK150168_s6000_e8000 | K150168.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK150168_s6000_e8000 | K150168.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK163626_s0_e2000 | K163626.txt | purpose for submission | Clearance of the ARIES Bordetella Assay for use with ARIES Systems. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qu... |
idK163626_s0_e2000 | K163626.txt | measurand | Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qu... |
idK163626_s0_e2000 | K163626.txt | type of test | Qualitative real-time polymerase chain reaction. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Q... |
idK163626_s0_e2000 | K163626.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: ... |
idK163626_s0_e2000 | K163626.txt | product code | OZZ | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: ... |
idK163626_s0_e2000 | K163626.txt | panel | Microbiology (83) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test:... |
idK163626_s0_e2000 | K163626.txt | intended use | The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from indivi... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Q... |
idK163626_s0_e2000 | K163626.txt | predicate device name | illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qu... |
idK163626_s0_e2000 | K163626.txt | applicant | Luminex Corporation | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: ... |
idK163626_s0_e2000 | K163626.txt | proprietary and established names | ARIES Bordetella Assay | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qualitat... |
idK163626_s0_e2000 | K163626.txt | regulation section | 866.3980 | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Q... |
idK163626_s18000_e20000 | K163626.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK163626_s18000_e20000 | K163626.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK152386_s0_e2000 | K152386.txt | purpose for submission | This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A virus (with subtype differentiation), Influenza B virus, Respiratory Syncytial virus (RSV) A and RSV B, Corona... | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A virus... |
idK152386_s0_e2000 | K152386.txt | type of test | Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A v... |
idK152386_s0_e2000 | K152386.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A ... |
idK152386_s0_e2000 | K152386.txt | panel | Microbiology (83) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A... |
idK152386_s0_e2000 | K152386.txt | applicant | Luminex Molecular Diagnostics, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A ... |
idK152386_s0_e2000 | K152386.txt | proprietary and established names | NxTAG® Respiratory Pathogen Panel | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A virus (wit... |
idK152386_s0_e2000 | K152386.txt | regulation section | 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A v... |
idK152386_s2000_e4000 | K152386.txt | predicate device name | BioFire Diagnostics, LLC FilmArray® Respiratory Panel | 3 Positive Positive Negative Positive None Positive Negative Positive Positive Negative2 Positive Negative Positive Negative2 Negative Positive Positive Influenza A (so subtype detected) Positive Negative Negative Negative Retest1 1 If the retest provides the same result for influenza A (no subtype detected), contact l... |
idK152386_s40000_e42000 | K152386.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK152386_s40000_e42000 | K152386.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK170974_s0_e2000 | K170974.txt | purpose for submission | New device | 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 Performed... |
idK170974_s0_e2000 | K170974.txt | type of test | Quantitative and Semi-quantitative Flow Cytometric Immunoassays | ) 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... |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.