FDA Review Panel · MI

FDA 510(k) Microbiology Devices

FDA 510(k) Microbiology Devices - Regulatory Overview

FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.

Key device types:

  • Blood culture systems - automated incubation and detection platforms
  • Microbial identification - MALDI-TOF, biochemical and molecular ID systems
  • Antimicrobial susceptibility testing - MIC determination and breakpoint analysis
  • Rapid infectious disease tests - influenza, strep, RSV, COVID-19 antigen and molecular tests
  • Molecular diagnostics - PCR panels for respiratory, GI and STI pathogens

7095
Total
7032
Cleared
150d
Avg (2y)
1976
Since
7095 Microbiology devices
926–950 of 7095
Cleared Dec 09, 2015
ProParaFlu+ Assay
K153223 · Hologic, Inc.
OOU · Parainfluenza Multiplex Nucleic Acid Assay · 33d
Cleared Dec 03, 2015
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
K151226 · Cepheid
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 210d
Cleared Dec 01, 2015
CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
K153148 · Centers For Disease Control and Prevention (Cdc)
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 32d
Cleared Nov 24, 2015
HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40
K152846 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 56d
Cleared Nov 24, 2015
HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
K152838 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 56d
Cleared Nov 20, 2015
ProFlu+ Assay
K153219 · Hologic, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 15d
Cleared Nov 12, 2015
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
K150358 · Gold Standard Diagnostics
GMQ · Antigens, Nontreponemal, All · 273d
Cleared Nov 10, 2015
illumigene Pertussis DNA Amplification Assay
K152285 · Meridian Bioscience, Inc.
OZZ · Bordetella Pertussis Dna Assay System · 90d
Cleared Oct 27, 2015
BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit
K152874 · Becton, Dickinson and Co.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 27d
Cleared Oct 27, 2015
BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit
K152870 · Becton, Dickinson and Co.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 27d
Cleared Oct 23, 2015
illumigene Mycoplasma DNA Amplification Assay
K152800 · Meridian Bioscience, Inc.
OZX · Mycoplasma Pneumoniae Dna Assay System · 25d
Cleared Oct 16, 2015
Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
K151565 · Cepheid
OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System · 128d
Cleared Oct 13, 2015
BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks
K152516 · Becton, Dickinson and Company
JTN · Susceptibility Test Discs, Antimicrobial · 40d
Not Cleared Oct 08, 2015
FilmArray Meningitis/Encephalitis(ME) Panel
DEN150013 · Biofire Diagnostics, LLC
PLO · Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System · 182d
Cleared Oct 07, 2015
Etest Ceftaroline (0.002 - 32ug/ml)
K151873 · Biomerieux S.A.
JWY · Manual Antimicrobial Susceptibility Test Systems · 90d
Cleared Oct 06, 2015
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
K151906 · Luminex Corporation
PGI · Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples · 85d
Cleared Oct 01, 2015
JBAIDS Influenza A & B Detection Kit
K152523 · U.S Army Medical Materiel Development Activity
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 28d
Cleared Oct 01, 2015
hemoFISH Masterpanel
K150031 · Miacom Diagnostics GmbH
JSS · Kit, Identification, Enterobacteriaceae · 266d
Cleared Sep 21, 2015
Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
K152408 · Focus Diagnostics, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 27d
Cleared Sep 16, 2015
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
K152346 · Beckman Coulter, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 27d
Cleared Sep 04, 2015
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
K143653 · Nanosphere, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 255d
Cleared Aug 28, 2015
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
K150962 · Focus Diagnostics
OQO · Herpes Simplex Virus Nucleic Acid Amplification Assay · 140d
Cleared Aug 28, 2015
Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)
K150556 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 177d
Cleared Aug 25, 2015
BD MAX Enteric Parasite Panel, BD MAX Instrument
K143648 · Becton, Dickinson and Company
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 246d
Cleared Aug 12, 2015
Alere Signify H. pylori Whole Blood, Serum, Plasma
K151935 · Alere San Diego, Incorporated
LYR · Helicobacter Pylori · 29d

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All categories 7095 JWY Manual Antimicrobial Susceptibility Test Systems 441 JTN Susceptibility Test Discs, Antimicrobial 323 JSJ Culture Media, Selective And Non-differential 299 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 291 JSI Culture Media, Selective And Differential 267 JTO Discs, Strips And Reagents, Microorganism Differentiation 239 JSG Culture Media, Non-selective And Non-differential 198 JSH Culture Media, Non-selective And Differential 142 LSR Reagent, Borrelia Serological Reagent 112 JSM Culture Media, Non-propagating Transport 110 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 104 GTZ Antisera, All Groups, Streptococcus Spp. 99 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 92 LYR Helicobacter Pylori 91 JSF Culture Media, Single Biochemical Test 87