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
1001–1025 of 5928
Cleared May 13, 2014
IMDX HSV-1/2 FOR ABBOTT M2000
K140198 · Intelligent Medical Devices, Inc.
OQO · Herpes Simplex Virus Nucleic Acid Amplification Assay · 106d
Not Cleared May 13, 2014
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
DEN140004 · Diagnostic Hybrids, Inc.
PGI · Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples · 81d
Cleared May 09, 2014
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
K140354 · Abbott Molecular, Inc.
LSL · Dna-reagents, Neisseria · 86d
Cleared May 06, 2014
BD MAX(TM) ENTERIC BACTERIAL PANEL
K140111 · Becton, Dickinson and Company
PCI · Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System · 111d
Cleared May 05, 2014
COBAS CT/NG V2.0 TEST
K140887 · Roche Molecular Systems, Inc.
LSL · Dna-reagents, Neisseria · 28d
Cleared May 02, 2014
FILMARRAY GASTROINTESTINAL (GI) PANEL
K140407 · Biofire Diagnostics
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 73d
Cleared Apr 25, 2014
INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K140857 · Centers For Disease Control and Prevention
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 22d
Cleared Apr 25, 2014
INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K140851 · Centers For Disease Control and Prevention
OEP · Influenza A Virus Subtype Differentiation Nucleic Acid Assay · 22d
Not Cleared Apr 16, 2014
LYRA DIRECT STREP ASSAY
DEN140005 · Quidel Corporation
PGX · Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System · 22d
Cleared Apr 04, 2014
ARTUS C. DIFFICILE QS-RGQ MDX KIT
K133936 · QIAGEN GmbH
OZN · C. Difficile Toxin Gene Amplification Assay · 102d
Cleared Mar 26, 2014
AMIPLIVUE HSV 1&2 ASSAY
K140029 · Quidel Corporation
OQO · Herpes Simplex Virus Nucleic Acid Amplification Assay · 79d
Cleared Mar 25, 2014
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
K133673 · Meridian Bioscience, Inc.
OZZ · Bordetella Pertussis Dna Assay System · 116d
Not Cleared Mar 21, 2014
SIMPLEXA HSV 1&2 DIRECT
DEN130049 · Focus Diagnostics
PGH · Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel · 116d
Cleared Feb 28, 2014
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
K131605 · Roche Diagnostics
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 270d
Cleared Feb 28, 2014
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
K131334 · Gold Standard Diagnostics
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 295d
Cleared Feb 27, 2014
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
K133773 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 77d
Cleared Feb 14, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
K132909 · Becton, Dickinson and Company
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 150d
Cleared Jan 31, 2014
WONDFO RAPID STREP A TEST
K133343 · Guangzhou Wondfo Biotech Co., Ltd.
GTY · Antigens, All Groups, Streptococcus Spp. · 93d
Cleared Jan 31, 2014
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K133038 · Trek Diagnostic Systems
NGZ · Susceptibility Test Plate, Antifungal · 127d
Cleared Jan 17, 2014
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT
K133869 · Center For Disease Control and Prevention (Cdc)
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 28d
Cleared Jan 08, 2014
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
K132843 · Nanosphere, Inc.
PEN · Gram-negative Bacteria And Associated Resistance Markers · 120d
Cleared Jan 03, 2014
TRU FLU
K133714 · Meridian Bioscience, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 29d
Cleared Dec 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
K132674 · Becton, Dickinson and Company
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 122d
Cleared Dec 20, 2013
BD MAX MRSA XT, BD MAX INSTRUMENT
K133605 · Geneohm Sciences Canada, Inc.
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 25d
Cleared Dec 20, 2013
AMPLIVUE GBS ASSAY
K133503 · Quidel Corporation
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 36d

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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