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idK160082_s0_e2000 | K160082.txt | measurand | Not applicable. | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory... |
idK160082_s0_e2000 | K160082.txt | type of test | Collection and transport culture medium device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for labora... |
idK160082_s0_e2000 | K160082.txt | classification | Class I | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for labor... |
idK160082_s0_e2000 | K160082.txt | panel | 83- Microbiology | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for labo... |
idK160082_s0_e2000 | K160082.txt | intended use | The Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for labora... |
idK160082_s0_e2000 | K160082.txt | predicate device name | Copan Venturi Transystem Cary-Blair Medium product (132C) | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory... |
idK160082_s0_e2000 | K160082.txt | applicant | Puritan Medical Products, LLC | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for labor... |
idK160082_s0_e2000 | K160082.txt | proprietary and established names | Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory cult... |
idK160082_s0_e2000 | K160082.txt | regulation section | 866.2390; Transport Culture Medium | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for labora... |
idK160082_s6000_e8000 | K160082.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK160082_s6000_e8000 | K160082.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK161510_s0_e2000 | K161510.txt | purpose for submission | To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems C. M... |
idK161510_s0_e2000 | K161510.txt | type of test | Automated quantitative or qualitative antimicrobial susceptibility test for Ceftolozane/Tazobactam | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems ... |
idK161510_s0_e2000 | K161510.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems... |
idK161510_s0_e2000 | K161510.txt | panel | Microbiology (83) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) System... |
idK161510_s0_e2000 | K161510.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. and ... | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems ... |
idK161510_s0_e2000 | K161510.txt | predicate device name | VITEK®2 AST-GN Doxycycline | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems C. M... |
idK161510_s0_e2000 | K161510.txt | applicant | bioMérieux, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems... |
idK161510_s0_e2000 | K161510.txt | proprietary and established names | VITEK 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥32 µg/mL) | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems C. Measur... |
idK161510_s0_e2000 | K161510.txt | regulation section | 221 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems ... |
idK161510_s6000_e8000 | K161510.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK161510_s6000_e8000 | K161510.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK152614_s0_e2000 | K152614.txt | purpose for submission | To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems) in the qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequence from... | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert In... |
idK152614_s0_e2000 | K152614.txt | measurand | blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert In... |
idK152614_s0_e2000 | K152614.txt | type of test | Qualitative real-time polymerase chain reaction (PCR) assay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXper... |
idK152614_s0_e2000 | K152614.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpe... |
idK152614_s0_e2000 | K152614.txt | panel | 83-Microbiology | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXp... |
idK152614_s0_e2000 | K152614.txt | predicate device name | Xpert ® vanA Assay | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert In... |
idK152614_s0_e2000 | K152614.txt | applicant | Cepheid | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpe... |
idK152614_s0_e2000 | K152614.txt | proprietary and established names | Xpert® Carba-R | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinit... |
idK152614_s0_e2000 | K152614.txt | regulation section | 21 CFR 866.1640 (Antimicrobial susceptibility test powder) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXper... |
idK152614_s16000_e18000 | K152614.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK152614_s16000_e18000 | K152614.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK180264_s0_e2000 | K180264.txt | measurand | Anti-Borrelia burgdorferi (IgM and IgG) antibodies | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Stand... |
idK180264_s0_e2000 | K180264.txt | type of test | Enzyme Immunoassay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Stan... |
idK180264_s0_e2000 | K180264.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Sta... |
idK180264_s0_e2000 | K180264.txt | product code | LSR; Reagent, Borrelia Serological Reagent | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Sta... |
idK180264_s0_e2000 | K180264.txt | panel | Microbiology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold St... |
idK180264_s0_e2000 | K180264.txt | intended use | The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must ... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Stan... |
idK180264_s0_e2000 | K180264.txt | applicant | Gold Standard Diagnostics | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Sta... |
idK180264_s0_e2000 | K180264.txt | regulation section | 21 CFR 866.3830; Treponema pallidum treponemal test reagents. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Stan... |
idK180264_s2000_e4000 | K180264.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. | ... |
idK180264_s2000_e4000 | K180264.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK143502_s0_e2000 | K143502.txt | purpose for submission | New device | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143502 B. Purpose for Submission: New device C. Measurand: Opiates D. Type of Test: Qualitative and semi-quantitative homogeneous enzyme immunoassay E. Applicant: Immunalysis Corporation F. Proprietary and Established Names: Immu... |
idK143502_s0_e2000 | K143502.txt | measurand | Opiates | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143502 B. Purpose for Submission: New device C. Measurand: Opiates D. Type of Test: Qualitative and semi-quantitative homogeneous enzyme immunoassay E. Applicant: Immunalysis Corporation F. Proprietary and Established Names: Immu... |
idK143502_s0_e2000 | K143502.txt | type of test | Qualitative and semi-quantitative homogeneous enzyme immunoassay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143502 B. Purpose for Submission: New device C. Measurand: Opiates D. Type of Test: Qualitative and semi-quantitative homogeneous enzyme immunoassay E. Applicant: Immunalysis Corporation F. Proprietary and Established Names: ... |
idK143502_s0_e2000 | K143502.txt | intended use | See Indication(s) for use below. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143502 B. Purpose for Submission: New device C. Measurand: Opiates D. Type of Test: Qualitative and semi-quantitative homogeneous enzyme immunoassay E. Applicant: Immunalysis Corporation F. Proprietary and Established Names: ... |
idK143502_s0_e2000 | K143502.txt | applicant | Immunalysis Corporation | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143502 B. Purpose for Submission: New device C. Measurand: Opiates D. Type of Test: Qualitative and semi-quantitative homogeneous enzyme immunoassay E. Applicant: Immunalysis Corporation F. Proprietary and Established Names:... |
idK143502_s6000_e8000 | K143502.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK143502_s6000_e8000 | K143502.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK182513_s0_e2000 | K182513.txt | purpose for submission | New device 510(k) clearance for the FluChip-8G Influenza A+B Assay | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream microar... |
idK182513_s0_e2000 | K182513.txt | measurand | Influenza A and influenza B viral nucleic acids. | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream microar... |
idK182513_s0_e2000 | K182513.txt | type of test | Qualitative multiplex one-step RT-PCR followed by downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream mic... |
idK182513_s0_e2000 | K182513.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream mi... |
idK182513_s0_e2000 | K182513.txt | panel | Microbiology (83) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream m... |
idK182513_s0_e2000 | K182513.txt | applicant | InDevR, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream mi... |
idK182513_s0_e2000 | K182513.txt | proprietary and established names | FluChip-8G Influenza A+B Assay (FC8G assay) | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream microarray-b... |
idK182513_s0_e2000 | K182513.txt | regulation section | 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream mic... |
idK182513_s12000_e14000 | K182513.txt | predicate device name | CDC Human Influenza Virus Real-Time PCR Diagnostic Panel | est a valid result is generated, follow the recommended actions for that result. No Call: Assay Failure (Hybridization Control) This result is likely due to an issue in the hybridization step. Retest Specimen If upon retest a valid result is generated, follow the recommended actions for that result. No Call: Assay Fail... |
idK182513_s40000_e42000 | K182513.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | ... |
idK182513_s40000_e42000 | K182513.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK142965_s0_e2000 | K142965.txt | purpose for submission | New device | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images on a c... |
idK142965_s0_e2000 | K142965.txt | type of test | Manual scoring of digital images on a computer monitor of progesterone receptor (PR) (1E2) immunohistochemistry (IHC) stained slides using the VENTANA iScan HT scanner. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images on... |
idK142965_s0_e2000 | K142965.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images o... |
idK142965_s0_e2000 | K142965.txt | product code | OEO - Automated Digital Image Manual Interpretation Microscope | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images o... |
idK142965_s0_e2000 | K142965.txt | panel | Pathology (88) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images ... |
idK142965_s0_e2000 | K142965.txt | predicate device name | Virtuoso™ System for IHC PR (1E2) | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images on a c... |
idK142965_s0_e2000 | K142965.txt | applicant | Ventana Medical Systems, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images o... |
idK142965_s0_e2000 | K142965.txt | regulation section | 21 CFR §864.1860, Immunohistochemistry reagents and kits | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images on... |
idK142965_s4000_e6000 | K142965.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK142965_s4000_e6000 | K142965.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK182389_s0_e2000 | K182389.txt | purpose for submission | Expand Intended Use to include pediatric subjects under the age of 2 years old. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Pe... |
idK182389_s0_e2000 | K182389.txt | type of test | The Sysmex XN-L Automated Hematology Analyzer (hereafter, the XN-L analyzer) classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. ... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests P... |
idK182389_s0_e2000 | K182389.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests ... |
idK182389_s0_e2000 | K182389.txt | product code | GKZ, Counter, Differential Cell | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests ... |
idK182389_s0_e2000 | K182389.txt | panel | Hematology (81) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests... |
idK182389_s0_e2000 | K182389.txt | predicate device name | Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Pe... |
idK182389_s0_e2000 | K182389.txt | applicant | Sysmex America Inc. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests ... |
idK182389_s0_e2000 | K182389.txt | regulation section | 21 CFR 864.5220, Automated differential cell counter | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests P... |
idK182389_s6000_e8000 | K182389.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK182389_s6000_e8000 | K182389.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK171974_s0_e2000 | K171974.txt | purpose for submission | New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcripta... |
idK171974_s0_e2000 | K171974.txt | measurand | Fusion Protein Gene | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcripta... |
idK171974_s0_e2000 | K171974.txt | type of test | Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcript... |
idK171974_s0_e2000 | K171974.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcrip... |
idK171974_s0_e2000 | K171974.txt | panel | Microbiology (83) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcri... |
idK171974_s0_e2000 | K171974.txt | intended use | The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV vira... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcript... |
idK171974_s0_e2000 | K171974.txt | predicate device name | Lyra RSV+hMPV Assay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcripta... |
idK171974_s0_e2000 | K171974.txt | applicant | Quidel Corporation | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcrip... |
idK171974_s0_e2000 | K171974.txt | proprietary and established names | Solana RSV+hMPV Assay | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcriptase - H... |
idK171974_s0_e2000 | K171974.txt | regulation section | 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcript... |
idK171974_s10000_e12000 | K171974.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK171974_s10000_e12000 | K171974.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK150144_s0_e2000 | K150144.txt | purpose for submission | Clearance of a new device | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Control Pl... |
idK150144_s0_e2000 | K150144.txt | measurand | Fibrinogen | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Control Pl... |
idK150144_s0_e2000 | K150144.txt | type of test | Quality Control Material, Assayed | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Contro... |
idK150144_s0_e2000 | K150144.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Contr... |
idK150144_s0_e2000 | K150144.txt | product code | GGN, Plasma, Coagulation Control | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Contr... |
idK150144_s0_e2000 | K150144.txt | panel | 81 (Hematology) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Cont... |
idK150144_s0_e2000 | K150144.txt | predicate device name | Precision Biologic Inc., Cryocheck Low Fibrinogen Control | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Control Pl... |
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