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
476–500 of 5926
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
Cleared Jun 03, 2020
DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
K200506 · Chembio Diagnostic Systems
QFO · Zika Virus Serological Reagents · 93d
Cleared May 17, 2020
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
K200866 · Hologic, Inc.
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 46d
Not Cleared May 11, 2020
NP Screen
DEN190031 · Advance Sentry Corporation
OJY · Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers · 322d
Cleared May 07, 2020
ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
K200512 · Biom?rieux SA
JWY · Manual Antimicrobial Susceptibility Test Systems · 66d
Cleared Apr 28, 2020
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
K200590 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 53d
Cleared Apr 27, 2020
binx io CT/NG Assay and binx io CT/NG System
K200533 · Binx Health, Inc.
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 56d

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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