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

7048
Total
6986
Cleared
159d
Avg (2y)
1976
Since
1404 Microbiology devices
451–475 of 1404
Cleared Mar 22, 2021
Capture-CMV
K203612 · Immucor, Inc.
LJO · Antigen, Iha, Cytomegalovirus · 102d
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 IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
K202573 · DiaSorin, Inc.
LSR · Reagent, Borrelia Serological Reagent · 167d
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 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
Cleared Sep 02, 2020
cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
K202215 · Roche Molecular Systems, Inc.
QMI · Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna · 27d
Cleared Aug 30, 2020
LabPro Data Management System
K201405 · Beckman Coulter, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 94d
Cleared Aug 22, 2020
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
K201505 · Diasorin Molecular, LLC
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 78d
Not Cleared Jul 30, 2020
cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
DEN200015 · Roche Molecular Systems, Inc.
QLX · Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna · 150d
Cleared Jun 29, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
K201423 · Beckman Coulter, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 31d

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All categories 1404 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 167 JWY Manual Antimicrobial Susceptibility Test Systems 122 JTN Susceptibility Test Discs, Antimicrobial 71 QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents 31 LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems 30 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 30 JSJ Culture Media, Selective And Non-differential 29 JSM Culture Media, Non-propagating Transport 27 PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays 26 LSR Reagent, Borrelia Serological Reagent 25 PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System 25 QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections 23 MDB System, Blood Culturing 23 LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) 21 JSH Culture Media, Non-selective And Differential 21