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

7067
Total
7005
Cleared
149d
Avg (2y)
1976
Since
5926 Microbiology devices
701–725 of 5926
Cleared Mar 14, 2018
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
K173798 · Diasorin Molecular, LLC
PGI · Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples · 90d
Cleared Mar 08, 2018
BreathID Hp Lab System
K173777 · Exalenz Bioscience , Ltd.
MSQ · Test, Urea (breath Or Blood) · 86d
Cleared Mar 08, 2018
BreathID Hp System
K173772 · Exalenz Bioscience , Ltd.
MSQ · Test, Urea (breath Or Blood) · 86d
Cleared Feb 28, 2018
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
K173817 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 75d
Cleared Feb 28, 2018
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
K173691 · Quidel Corporation
LSR · Reagent, Borrelia Serological Reagent · 89d
Cleared Feb 27, 2018
LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
K173683 · DiaSorin, Inc.
PRI · Procalcitonin Assay · 88d
Cleared Feb 13, 2018
QuickVue Influenza A+B
K180288 · Quidel Corporation
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 12d
Cleared Feb 09, 2018
BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)
K173523 · Becton, Dickinson and Company
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 87d
Cleared Feb 06, 2018
Accula Flu A/Flu B Test
K171641 · Mesa Biotech, Inc.
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 249d
Cleared Feb 01, 2018
Sentosa SA201 HSV 1/2 Qualitative PCR Test
K172509 · Vela Diagnostics USA, Inc.
OQO · Herpes Simplex Virus Nucleic Acid Amplification Assay · 164d
Cleared Jan 26, 2018
Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
K173932 · Alere Scarborough, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 31d
Cleared Jan 22, 2018
CAMPYLOBACTER CHEK
K173219 · Techlab, Inc.
LQP · Campylobacter Spp. · 111d
Cleared Jan 22, 2018
CAMPYLOBACTER QUIK CHEK
K173217 · Techlab, Inc.
LQP · Campylobacter Spp. · 111d
Cleared Jan 09, 2018
Xpert Carba-R
K173263 · Cepheid
POC · System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen · 90d
Cleared Jan 05, 2018
BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)
K173252 · Becton, Dickinson and Company
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 87d
Cleared Dec 28, 2017
MRSASelect II
K171061 · Bio-Rad
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 262d
Cleared Dec 21, 2017
Solana GBS Assay
K173250 · Quidel Corporation
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 72d
Cleared Dec 21, 2017
Sofia Strep A+ FIA, Sofia 2 Analyzer
K171976 · Quidel Corporation
GTY · Antigens, All Groups, Streptococcus Spp. · 174d
Cleared Dec 19, 2017
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
K173307 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 62d
Cleared Dec 19, 2017
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL
K172944 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 84d
Cleared Dec 19, 2017
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
K171552 · Cepheid
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 207d
Cleared Dec 15, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
K172337 · Beckman Coulter, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 135d
Cleared Dec 13, 2017
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
K173502 · Alere Scarborough, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 30d
Cleared Dec 12, 2017
T2Candida 1.1 Panel
K173536 · T2biosystems, Inc.
PII · Candida Species Nucleic Acid Detection System · 27d
Cleared Dec 10, 2017
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
K172722 · Euroimmun Us, Inc.
LSR · Reagent, Borrelia Serological Reagent · 90d

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All categories 5926 JWY Manual Antimicrobial Susceptibility Test Systems 407 JTN Susceptibility Test Discs, Antimicrobial 316 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 284 JSJ Culture Media, Selective And Non-differential 264 JSI Culture Media, Selective And Differential 216 JTO Discs, Strips And Reagents, Microorganism Differentiation 194 JSG Culture Media, Non-selective And Non-differential 181 JSH Culture Media, Non-selective And Differential 115 LSR Reagent, Borrelia Serological Reagent 98 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 94 GTZ Antisera, All Groups, Streptococcus Spp. 84 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 79 JSM Culture Media, Non-propagating Transport 77 LYR Helicobacter Pylori 75 OCC Respiratory Virus Panel Nucleic Acid Assay System 74