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
876–900 of 4573
Cleared Dec 10, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K133474 · Princeton BioMeditech Corp.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 28d
Cleared Dec 02, 2013
COBAS CT/NG V2.0 TEST
K132270 · Roche Molecular Systems, Inc.
LSL · Dna-reagents, Neisseria · 133d
Cleared Nov 15, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
K133140 · Becton, Dickinson & CO
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 29d
Cleared Nov 15, 2013
VITEK 2 AST ST MEROPENEM
K132507 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 95d
Cleared Nov 13, 2013
BD Veritor™ System Flu A+B Assay
K133138 · Becton, Dickinson & CO
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 27d
Cleared Nov 07, 2013
BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
K132456 · Becton, Dickinson and Company
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 93d
Cleared Oct 10, 2013
VITEK 2 AST-ST TIGECYCLINE
K131779 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 115d
Cleared Oct 02, 2013
BD Veritor™ System Flu A+B Assay
K132693 · Becton, Dickinson and Company
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 34d
Cleared Sep 23, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132692 · Becton, Dickinson and Company
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 25d
Cleared Sep 13, 2013
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
K132573 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 28d
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 23, 2013
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
K130268 · Becton, Dickinson & CO
OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System · 200d
Not Cleared Aug 21, 2013
VITEK MS
DEN130013 · bioMerieux, Inc.
PEX · System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates · 231d
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
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
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 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
Cleared Jul 05, 2013
SOFIA INFLUENZA A+B FIA
K131606 · Quidel Corp.
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 32d
Cleared Jul 05, 2013
QUICK VUE INFLUENZA
K131599 · Quidel Corporation
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 32d
Cleared Jun 28, 2013
QUICKVUE INFLUENZA A+B
K131619 · Quidel Corp.
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 25d

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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