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
1151–1175 of 5928
Cleared May 03, 2012
APTIMA COMBO 2 ASSAY
K111409 · Gen-Probe, Inc.
LSL · Dna-reagents, Neisseria · 350d
Cleared May 01, 2012
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
K121044 · Meridian Bioscience, Inc.
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 25d
Not Cleared Apr 30, 2012
PORTRAIT ANALYZER
DEN120013 · Great Basin Scientific
OMN · C. Difficile Nucleic Acid Amplification Test Assay · 59d
Cleared Apr 11, 2012
BORRELIA BURGDORFERI IGG BLOT TEST
K113847 · Gold Standard Diagnostics
LSR · Reagent, Borrelia Serological Reagent · 104d
Cleared Apr 04, 2012
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
K113433 · Focus Diagnostics, Inc.
OMN · C. Difficile Nucleic Acid Amplification Test Assay · 135d
Cleared Apr 03, 2012
STAPHYLOCOCCUS QUICKFISH BC
K113371 · Advandx, Inc.
NXX · Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus · 139d
Cleared Mar 30, 2012
KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
K120563 · Microphage, Inc.
OUS · Methicillin Resistant Staphylococcus Aureus/methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt · 35d
Cleared Mar 28, 2012
CRAG LATERAL FLOW ASSAY (LFA)
K112422 · Immuno-Mycologics, Inc.
GMD · Antisera, Latex Agglutination, Cryptococcus Neoformans · 218d
Cleared Mar 26, 2012
BIOPLEX 2200 TORC IGG
K120572 · Bio-Rad Laboratories, Inc.
OMI · Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv · 28d
Cleared Mar 23, 2012
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K120049 · Becton, Dickinson and Company
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 77d
Cleared Mar 16, 2012
BD BACTEC Plus Aerobic/F Culture Vials (plastic)
K113558 · Becton, Dickinson and Company
MDB · System, Blood Culturing · 106d
Cleared Mar 15, 2012
QUIDEL MOLECULAR INFLUENZA A+B
K113777 · Quidel Corp.
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 85d
Cleared Mar 14, 2012
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
K120439 · Bio-Rad Laboratories, Inc.
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 30d
Cleared Mar 02, 2012
HELICOBACTER PYLORI ELISA IGG TEST KIT
K110745 · Gold Standard Diagnostics
LYR · Helicobacter Pylori · 351d
Cleared Mar 01, 2012
TRANSPORT CULTURE MEDIUM DEVICE
K113249 · Puritan Medical Products, LLC
JSM · Culture Media, Non-propagating Transport · 119d
Cleared Feb 28, 2012
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
K111893 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 238d
Cleared Feb 24, 2012
TRU LEGIONELLA
K113190 · Meridian Bioscience, Inc.
MJH · Legionella, Spp., Elisa · 116d
Cleared Feb 17, 2012
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
K111976 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 220d
Cleared Feb 17, 2012
TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
K112781 · Luminex Molecular Diagnostics, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 144d
Cleared Feb 16, 2012
BD MAX GBS ASSAY, BD MAX INSTRUMENT
K111860 · Becton, Dickinson & CO
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 231d
Cleared Feb 10, 2012
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
K113305 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 93d
Cleared Feb 06, 2012
ROTOR-GENE Q MDX
K113319 · QIAGEN GmbH
OOI · Real Time Nucleic Acid Amplification System · 88d
Cleared Feb 06, 2012
ARTUS INFL A/B RG RT-PCR KIT
K113323 · QIAGEN GmbH
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 88d
Cleared Feb 01, 2012
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
K110899 · Gold Standard Diagnostics
LYR · Helicobacter Pylori · 308d
Cleared Jan 24, 2012
COBAS 4800 CT / NG TEST
K110923 · Roche Molecular Systems, Inc.
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 298d

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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