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

7061
Total
6999
Cleared
155d
Avg (2y)
1976
Since
4573 Microbiology devices
451–475 of 4573
Cleared May 18, 2021
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
K202423 · Beckman Coulter, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 266d
Cleared Mar 22, 2021
Capture-CMV
K203612 · Immucor, Inc.
LJO · Antigen, Iha, Cytomegalovirus · 102d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K203296 · Gold Standard Diagnostics
LSR · Reagent, Borrelia Serological Reagent · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K203295 · Gold Standard Diagnostics
LSR · Reagent, Borrelia Serological Reagent · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K203292 · Gold Standard Diagnostics
LSR · Reagent, Borrelia Serological Reagent · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
K203289 · Gold Standard Diagnostics
LSR · Reagent, Borrelia Serological Reagent · 133d
Not Cleared Mar 17, 2021
BioFire Respiratory Panel 2.1 (RP2.1)
DEN200031 · Biofire Diagnostics, LLC
QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 302d
Cleared Mar 03, 2021
Cultura Collection and Transport System
K201674 · Merit Medical Systems, Inc.
JSM · Culture Media, Non-propagating Transport · 257d
Cleared Feb 18, 2021
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
K202574 · DiaSorin, Inc.
LSR · Reagent, Borrelia Serological Reagent · 167d
Cleared Feb 18, 2021
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
K202573 · DiaSorin, Inc.
LSR · Reagent, Borrelia Serological Reagent · 167d
Cleared Feb 16, 2021
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
K210234 · Roche Molecular Systems, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 19d
Cleared Feb 09, 2021
LIAISON Anti-HAV
K210272 · DiaSorin, Inc.
LOL · Hepatitis A Test (antibody And Igm Antibody) · 8d
Cleared Jan 29, 2021
cobas BKV
K203220 · Roche Molecular Systems, Inc.
QLX · Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna · 88d
Cleared Jan 21, 2021
cobas CTNG for use on cobas 6800/8800 systems
K202408 · Roche Molecular Systems, Inc.
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 153d
Cleared Dec 27, 2020
MBT Sepsityper
K193419 · Bruker Daltonik GmbH
QNJ · Mass Spectrometry, Microorganism Identification, Blood Culture · 384d
Cleared Dec 14, 2020
DNA/RNA Shield Collection Tube
K202641 · Zymo Research
QBD · Microbial Nucleic Acid Storage And Stabilization Device · 94d
Cleared Dec 04, 2020
Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
K193508 · Oxoid Limited (Part of Thermo Fisher Scientific)
JTN · Susceptibility Test Discs, Antimicrobial · 352d
Cleared Nov 20, 2020
FilmArray Global Fever Panel External Control Kit
K202382 · Biofire Defense, LLC
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 92d
Not Cleared Nov 20, 2020
FilmArray Global Fever Panel
DEN200043 · Biofire Defense, LLC
QMV · Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness · 147d
Cleared Nov 16, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
K202343 · Beckman Coulter, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 90d
Cleared Nov 09, 2020
Accula Strep A Test
K201269 · Mesa Biotech, Inc.
PGX · Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System · 181d
Cleared Oct 21, 2020
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
K201438 · Arlington Scientific, Inc. (Asi)
GMQ · Antigens, Nontreponemal, All · 142d
Cleared Sep 28, 2020
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
K193299 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 306d
Cleared Sep 17, 2020
eNAT molecular collection and preservation medium
K201849 · Copan Italia Spa
QBD · Microbial Nucleic Acid Storage And Stabilization Device · 73d
Cleared Sep 15, 2020
Accelerate Pheno System, Accelerate PhenoTest BC Kit
K192665 · Accelerate Diagnostics, Inc.
PRH · Positive Blood Culture Identification And Ast Kit · 356d

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All categories 4573 JWY Manual Antimicrobial Susceptibility Test Systems 361 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 282 JTN Susceptibility Test Discs, Antimicrobial 276 JSJ Culture Media, Selective And Non-differential 232 JSI Culture Media, Selective And Differential 175 JSG Culture Media, Non-selective And Non-differential 168 JTO Discs, Strips And Reagents, Microorganism Differentiation 144 JSH Culture Media, Non-selective And Differential 98 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 75 GRM Antisera, All Groups, Salmonella Spp. 66 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 62 GTZ Antisera, All Groups, Streptococcus Spp. 59 JSF Culture Media, Single Biochemical Test 58 MDB System, Blood Culturing 54 GNC Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. 51