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

7095
Total
7032
Cleared
150d
Avg (2y)
1976
Since
7095 Microbiology devices
1076–1100 of 7095
Cleared Sep 09, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K132465 · Princeton BioMeditech Corp.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 33d
Cleared Sep 06, 2013
QUIDEL MOLECULAR RSV + HMPV ASSAY
K131813 · Quidel Corp.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 78d
Cleared Aug 29, 2013
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K131728 · Quidel Corp.
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 78d
Cleared Aug 28, 2013
LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II
K132234 · DiaSorin, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 41d
Cleared Aug 26, 2013
PROPARAFLU+ ASSAY
K132238 · Gen-Probe Prodesse, Inc.
OOU · Parainfluenza Multiplex Nucleic Acid Assay · 39d
Cleared Aug 26, 2013
PRODESSE PROFAST+ ASSAY
K132237 · Gen-Probe Prodesse, Inc.
OQW · 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification · 39d
Cleared Aug 23, 2013
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
K130268 · Becton, Dickinson & CO
OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System · 200d
Cleared Aug 22, 2013
SAS FLUALERT A & B, SAS INFLUENZA A TEST
K132352 · Sa Scientific , Ltd.
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 24d
Cleared Aug 21, 2013
IMDX FLU A/B AND RSV FOR ABBOTT M2000
K131584 · Intelligent Medical Devices, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 82d
Not Cleared Aug 21, 2013
VITEK MS
DEN130013 · bioMerieux, Inc.
PEX · System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates · 231d
Cleared Aug 14, 2013
PRO HMPV+ ASSAY
K132200 · Gen-Probe Prodesse, Inc.
OEM · Human Metapneumovirus (hmpv) Rna Assay System · 29d
Cleared Aug 14, 2013
PROADENO+ ASSAY
K132159 · Gen-Probe Prodesse, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 33d
Cleared Aug 13, 2013
SOFIA(R) RSV FIA
K130398 · Quidel Corp.
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 175d
Cleared Aug 09, 2013
PRODESSE PROFLU+ ASSAY
K132129 · Gen-Probe Prodesse, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 30d
Cleared Aug 09, 2013
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
K131441 · DiaSorin, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 81d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132259 · Becton, Dickinson and Company
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 19d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132256 · Becton, Dickinson and Company
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 19d
Cleared Aug 05, 2013
JBAIDS ANTHRAX DETECTION KIT
K131930 · Biofire Diagnostics, Inc.
NHT · Assay, Nucleic Acid Amplification, Bacillus Anthracis · 39d
Cleared Jul 31, 2013
JBAIDS TULAREMIA DETECTION KIT
K131936 · Biofire Diagnostics, Inc.
OEH · Joint Biological Agent Identification And Diagnostic System (jbaids) Tularemia Detection Kit · 34d
Cleared Jul 31, 2013
JBAIDS PLAGUE DETECTION KIT
K131729 · Biofire Diagnostics, Inc.
OIH · Yersinia Spp. Reagents · 49d
Not Cleared Jul 25, 2013
XPERT MTB/RIF ASSAY
DEN130032 · Cepheid
PEU · System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen · 44d
Cleared Jul 21, 2013
GRAM-NEGATIVE QUICKFISH BC
K123418 · Advandx, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 257d
Cleared Jul 17, 2013
IMDX VANR FOR ABBOTT M2000
K123753 · Intelligent Medical Devices, Inc.
NIJ · System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species · 223d
Cleared Jul 12, 2013
REMEL XPECT FLU A&B
K131804 · Remel, Inc.
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 23d
Cleared Jul 10, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
K131331 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 62d

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All categories 7095 JWY Manual Antimicrobial Susceptibility Test Systems 441 JTN Susceptibility Test Discs, Antimicrobial 323 JSJ Culture Media, Selective And Non-differential 299 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 291 JSI Culture Media, Selective And Differential 267 JTO Discs, Strips And Reagents, Microorganism Differentiation 239 JSG Culture Media, Non-selective And Non-differential 198 JSH Culture Media, Non-selective And Differential 142 LSR Reagent, Borrelia Serological Reagent 112 JSM Culture Media, Non-propagating Transport 110 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 104 GTZ Antisera, All Groups, Streptococcus Spp. 99 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 92 LYR Helicobacter Pylori 91 JSF Culture Media, Single Biochemical Test 87