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
1776–1800 of 7095
Cleared Feb 26, 2004
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
K033479 · Remel, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 115d
Cleared Feb 25, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)
K033940 · Dade Behring, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 68d
Cleared Feb 11, 2004
WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
K023889 · Wiener Laboratories Saic
MIU · Enzyme Linked Immunosorbent Assay, T. Cruzi · 447d
Cleared Feb 10, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
K032706 · Dade Behring, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 161d
Cleared Feb 03, 2004
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K033522 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 88d
Cleared Feb 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML
K033784 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 61d
Cleared Feb 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE
K033889 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 49d
Cleared Jan 23, 2004
DUOPATH VEROTOXINS GLISA TEST
K031367 · Emd Chemicals, Inc.
GNA · Antisera, All Types, Escherichia Coli · 268d
Cleared Jan 21, 2004
IDEIA PCE CHLAMYDIA
K033865 · Dakocytomation, Ltd.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 40d
Cleared Jan 16, 2004
MODIFICATION TO SERAQUEST EB VCA IGG
K033915 · Quest Intl., Inc.
LSE · Epstein-barr Virus, Other · 29d
Cleared Jan 15, 2004
MODIFICATION TO SERAQUEST VCA IGM
K033780 · Quest Intl., Inc.
LJN · Antibody Igm, If, Epstein-barr Virus · 42d
Cleared Jan 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE
K033557 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 63d
Cleared Jan 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
K033560 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 63d
Cleared Dec 31, 2003
GEN-PROBE APTIMA COMBO 2 ASSAY
K032554 · Gen-Probe, Inc.
LSL · Dna-reagents, Neisseria · 134d
Cleared Dec 24, 2003
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS
K032194 · Gen-Probe, Inc.
LSL · Dna-reagents, Neisseria · 159d
Cleared Dec 19, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
K033558 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 37d
Cleared Dec 09, 2003
REDLINE ANTHRAX ALERT TEST
K030370 · Tetracore, Inc.
NPO · Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody · 308d
Cleared Dec 05, 2003
IMMUNOCARDSTAT HPSA
K032222 · Meridian Bioscience, Inc.
LYR · Helicobacter Pylori · 137d
Cleared Nov 26, 2003
LEGIONELLA PNEUMOPHILA IGG/IGM
K033051 · Trinity Biotech USA
MJH · Legionella, Spp., Elisa · 58d
Cleared Nov 26, 2003
HERPES GROUP IGG
K033059 · Trinity Biotech, Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 58d
Cleared Nov 26, 2003
MYCOPLASMA IGG
K033064 · Trinity Biotech USA
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 58d
Cleared Nov 26, 2003
PYLORI IGG
K033067 · Trinity Biotech USA
LYR · Helicobacter Pylori · 58d
Cleared Nov 26, 2003
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
K033070 · Trinity Biotech USA
LSR · Reagent, Borrelia Serological Reagent · 58d
Cleared Nov 26, 2003
CHLAMYDIA IGG ELISA TEST SYSTEM
K033079 · Trinity Biotech USA
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 58d
Cleared Nov 26, 2003
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K033083 · Trinity Biotech USA
LSR · Reagent, Borrelia Serological Reagent · 58d

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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