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
5928 Microbiology devices
926–950 of 5928
Cleared Jul 16, 2015
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A
K151690 · Alere Scarborough, Inc.
OOI · Real Time Nucleic Acid Amplification System · 23d
Cleared Jul 09, 2015
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
K141133 · BIOMERIEUX
LYR · Helicobacter Pylori · 434d
Cleared Jul 02, 2015
MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
K150039 · Siemens Healthcare Diagnostics, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 174d
Cleared Jul 02, 2015
Theranos Herpes Simplex Virus-1 IgG Assay
K143236 · Theranos, Inc.
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 232d
Cleared Jun 23, 2015
Solana GAS Assay, Solana instrument
K150868 · Quidel Corporation
PGX · Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System · 83d
Cleared Jun 10, 2015
BD Veritor (TM) System for the Rapid Detection of Flu A+B
K151291 · Becton, Dickinson and Company
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 26d
Cleared Jun 08, 2015
BD Veritor™ System Flu A+B Assay
K151301 · Becton, Dickinson and Company
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 24d
Cleared Jun 01, 2015
cobas HSV 1 and 2 Test
K150617 · Roche Molecular Systems, Inc.
OQO · Herpes Simplex Virus Nucleic Acid Amplification Assay · 83d
Cleared May 29, 2015
Para-Fix C&S Medium
K150887 · Medical Chemical Corporation
JSM · Culture Media, Non-propagating Transport · 57d
Cleared May 20, 2015
cobas Cdiff Test
K142422 · Roche Molecular Systems, Inc.
OZN · C. Difficile Toxin Gene Amplification Assay · 265d
Cleared May 04, 2015
EUROIMMUN LYME ELISA(IgG/IgM)
K142038 · Euroimmun US
LSR · Reagent, Borrelia Serological Reagent · 280d
Cleared Apr 21, 2015
Portrait GBS Assay
K143312 · Great Basin Corporation
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 154d
Cleared Apr 16, 2015
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC
K143592 · The Surgeon General, Department of the Army
NVQ · Bacteriophage And Controls, B. Anthracis Lysis · 119d
Cleared Apr 10, 2015
COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
K142094 · Copan Italia Spa
JSM · Culture Media, Non-propagating Transport · 252d
Cleared Apr 01, 2015
Sensititre Susceptibility plates
K143288 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 135d
Cleared Mar 31, 2015
ALERE I STREP A
K141757 · Alere Scarborough, Inc.
PGX · Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System · 274d
Cleared Mar 27, 2015
MALDI Biotyper CA System
K142677 · Bruker Daltonics, Inc.
PEX · System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates · 189d
Cleared Mar 18, 2015
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
K143651 · Focus Diagnostics, Inc.
PGX · Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System · 85d
Cleared Mar 17, 2015
AmpliVue Trichomonas Assay
K143329 · Quidel Corporation
OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System · 117d
Cleared Mar 11, 2015
LIAISON VZV IgG, LIAISON Control VZV IgG
K150375 · DiaSorin, Inc.
LFY · Enzyme Linked Immunoabsorbent Assay, Varicella-zoster · 26d
Cleared Mar 05, 2015
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
K143526 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 83d
Cleared Mar 02, 2015
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)
K142338 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 193d
Cleared Feb 25, 2015
MCC Para-Fix CARY BLAIR MEDIUM
K141506 · Medical Chemical Corporation
JSM · Culture Media, Non-propagating Transport · 264d
Cleared Feb 19, 2015
Sensititre Susceptibility Plates
K143381 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 86d
Cleared Feb 19, 2015
FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0
K143005 · Biofire Diagnostics, LLC
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 122d

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All categories 5928 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