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
551–575 of 5926
Cleared Sep 25, 2019
ARIES MRSA Assay
K191742 · Luminex Corporation
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 86d
Cleared Sep 19, 2019
HardyDisk AST Lefamulin 20µg (LMU20)
K192326 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 23d
Cleared Sep 04, 2019
MTS Imipenem 0.016-256 µg/mL
K191908 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 50d
Cleared Aug 29, 2019
BD MAX Check-Points CPO
K190613 · Check-Points Health B.V.
POC · System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen · 171d
Cleared Aug 23, 2019
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
K191809 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 49d
Cleared Aug 22, 2019
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
K191953 · Biomerieux S.A.
JWY · Manual Antimicrobial Susceptibility Test Systems · 31d
Cleared Aug 13, 2019
Elecsys Anti-HAV II
K190428 · Roche Diagnostics
LOL · Hepatitis A Test (antibody And Igm Antibody) · 172d
Cleared Aug 08, 2019
binx health io CT/NG Assay
K191352 · Binx Health, Inc.
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 80d
Cleared Aug 05, 2019
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
K191766 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 35d
Cleared Jul 31, 2019
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
K191931 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 12d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191398 · Zeus Scientific, Inc.
LSR · Reagent, Borrelia Serological Reagent · 66d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191240 · Zeus Scientific, Inc.
LSR · Reagent, Borrelia Serological Reagent · 82d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K190907 · Zeus Scientific, Inc.
LSR · Reagent, Borrelia Serological Reagent · 112d
Cleared Jul 24, 2019
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
K191729 · Roche Molecular Systems, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 27d
Cleared Jul 17, 2019
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
K191578 · Siemens Healthcare Diagnostics, Inc.
QFO · Zika Virus Serological Reagents · 33d
Cleared Jul 17, 2019
Fungitell STAT
K191167 · Associates of Cape Cod, Inc.
NQZ · Antigen, Invasive Fungal Pathogens · 77d
Cleared Jul 11, 2019
ID NOW Influenza A & B 2
K191534 · Abbott Diagnostics Scarborough, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 31d
Cleared Jul 01, 2019
BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)
K190905 · Becton, Dickinson and Company
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 84d
Cleared Jun 28, 2019
iC-GN iC-Cassette for use on the iC-System
K190341 · Icubate, Inc.
PEN · Gram-negative Bacteria And Associated Resistance Markers · 134d
Cleared Jun 25, 2019
Cepheid Xpert SA Nasal Complete Control Panel
K191168 · Microbiologics, Inc.
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 55d
Cleared Jun 20, 2019
Campylobacter Quik Chek
K191456 · Techlab, Inc.
LQP · Campylobacter Spp. · 20d
Cleared Jun 20, 2019
Campylobacter Chek
K191442 · Techlab, Inc.
LQP · Campylobacter Spp. · 21d
Cleared Jun 20, 2019
Cepheid Xpert MRSA NxG Control Panel
K191172 · Microbiologics, Inc.
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 50d
Cleared Jun 19, 2019
EntericBio Dx Assay
K182703 · Serosep , Ltd.
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 265d
Cleared Jun 13, 2019
SeraQuest HSV Type 2 Specific IgG
K181514 · Quest International, Inc.
MYF · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 · 370d

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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