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
351–375 of 4573
Cleared Jan 27, 2023
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin
K220803 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 315d
Cleared Jan 26, 2023
Revogene
K222779 · Meridian Bioscience, Inc.
OOI · Real Time Nucleic Acid Amplification System · 134d
Cleared Jan 20, 2023
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
K221899 · Thermo Fisher Scientific
NGZ · Susceptibility Test Plate, Antifungal · 204d
Cleared Jan 19, 2023
Biosci™ Inactivated Transport Medium, Biosci™ ITM
K220059 · Shenzhen Dakewe Bio-Engineering Co., Ltd.
QBD · Microbial Nucleic Acid Storage And Stabilization Device · 374d
Cleared Jan 18, 2023
Selux AST System
K211759 · Selux Diagnostics, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 590d
Cleared Jan 04, 2023
Elecsys Anti-HCV II (08837031190)
K221693 · Roche Diagnostics
MZO · Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus · 208d
Cleared Dec 21, 2022
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
K221826 · Becton, Dickinson and Company
JTN · Susceptibility Test Discs, Antimicrobial · 181d
Cleared Dec 20, 2022
IntelliSep test
K220991 · Cytovale, Inc.
QUT · Deformability Cytometry For Sepsis Risk Assessment · 260d
Cleared Dec 19, 2022
BreathID Hp System
K221896 · Meridian Bioscience Israel , Ltd.
MSQ · Test, Urea (breath Or Blood) · 172d
Cleared Dec 16, 2022
Copan FecalSwab Collection, Transport and Preservation System
K220052 · Copan Italia Spa
JSM · Culture Media, Non-propagating Transport · 344d
Cleared Dec 09, 2022
LIAISON Anti-HAV
K223403 · DiaSorin, Inc.
LOL · Hepatitis A Test (antibody And Igm Antibody) · 30d
Cleared Nov 17, 2022
Disposable Urine Collection Tube
K220739 · Zhejiang Gongdong Medical Technology Co., Ltd.
JSM · Culture Media, Non-propagating Transport · 248d
Cleared Nov 10, 2022
BreathID® Smart System
K223185 · Meridian Bioscience Israel , Ltd.
MSQ · Test, Urea (breath Or Blood) · 29d
Cleared Nov 05, 2022
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
K202755 · Diasorin Molecular, LLC
QDZ · Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection · 775d
Cleared Nov 04, 2022
cobas HCV
K221007 · Roche Molecular Systems, Inc.
MZP · Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus · 213d
Cleared Oct 27, 2022
FilmArray Pneumonia Panel plus
K222601 · Biofire Diagnostics, LLC
QDS · Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System · 59d
Cleared Oct 27, 2022
Architect CMV IgG
K220949 · Abbott Laboratories
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 209d
Cleared Oct 22, 2022
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
K213804 · Roche Molecular Systems, Inc.
QQX · Respiratory Specimen Nucleic Acid Sars-cov-2 Test · 320d
Cleared Oct 20, 2022
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
K220870 · Biofire Defense, LLC
QMV · Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness · 209d
Cleared Oct 13, 2022
VITEK 2 AST-Gram Positive Cefoxitin Screen
K220805 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 209d
Cleared Oct 12, 2022
Elecsys HSV-2 IgG (08948887160)
K220924 · Roche Diagnostics
MYF · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 · 195d
Cleared Oct 12, 2022
Elecsys HSV-1 IgG (08948844160)
K220923 · Roche Diagnostics
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 195d
Cleared Oct 12, 2022
Elecsys CMV IgG
K220911 · Roche Diagnostics
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 197d
Cleared Oct 05, 2022
Colibrí System
K220546 · Copan Wasp Srl
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 222d
Cleared Sep 21, 2022
BD MAX Enteric Viral Panel
K220607 · Becton, Dickinson and Company
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 203d

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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 LSR Reagent, Borrelia Serological Reagent 51