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
5934 Microbiology devices
2851–2875 of 5934
Cleared Feb 08, 1995
LORACARBEF GRAM-NAGATIVE PANELS
K940917 · Baxter Diagnostics, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 348d
Cleared Feb 03, 1995
GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
K941459 · Baxter Diagnostics, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 316d
Cleared Feb 02, 1995
GCII AGAR WITH ISOVITALX(R) ENRICHMENT
K945569 · Becton Dickinson Microbiology Systems
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 114d
Cleared Jan 31, 1995
DRIED GRAM NEGATIVE/CEFMETAZOLE
K941317 · Baxter Diagnostics, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 319d
Cleared Jan 27, 1995
PROLEX (STREPTOCCAL GROUPING LATEX KIT)
K934383 · Pro-Lab, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 505d
Cleared Jan 27, 1995
BBL CRYSTAL MRSA ID SYSTEM
K941997 · Becton Dickinson Microbiology Systems
JWY · Manual Antimicrobial Susceptibility Test Systems · 277d
Cleared Jan 17, 1995
PASCO MIC AND MIC/ID PANELS
K946126 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 33d
Cleared Jan 09, 1995
MICRODILUTION/LORACARBEF PANELS
K942089 · Baxter Diagnostics, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 252d
Cleared Jan 09, 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE
K942267 · Baxter Diagnostics, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 244d
Cleared Dec 22, 1994
BIOMERIEUX HEMOLAB AT III
K934156 · Biomerieux Vitek, Inc.
JBQ · Antithrombin Iii Quantitation · 482d
Cleared Dec 19, 1994
IMX RUBELLA IGM ANTIBODY ASSAY
K931059 · Abbott Laboratories
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 658d
Cleared Dec 19, 1994
ABBOTT CHAGAS ANTIBODY EIA
K933716 · Abbott Laboratories
MIU · Enzyme Linked Immunosorbent Assay, T. Cruzi · 507d
Cleared Dec 19, 1994
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
K943317 · Diagnostic Products Corp.
LKT · Respiratory Syncytial Virus, Antigen, Antibody, Ifa · 161d
Cleared Dec 19, 1994
DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.
K944275 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 111d
Cleared Dec 19, 1994
AXSYM DIGOXIN
K944506 · Abbott Laboratories
KXT · Enzyme Immunoassay, Digoxin · 96d
Cleared Dec 15, 1994
ALAMAR ANTIBIOTIC SUSCEPTIBILITY
K941425 · Alamar Biosciences Laboratory, Inc.
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 267d
Cleared Dec 14, 1994
DIARLEX ROTA-ADENO
K942286 · Orion Diagnostica, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 236d
Cleared Dec 08, 1994
IMMUNOCARD H. PYLORI
K941560 · Meridian Diagnostics, Inc.
LYR · Helicobacter Pylori · 251d
Cleared Dec 02, 1994
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K943510 · Baxter Diagnostics, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 135d
Cleared Nov 28, 1994
REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST
K942093 · Medical Diagnostic Technologies, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 210d
Cleared Nov 21, 1994
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K944096 · Immuno Concepts, Inc.
DHN · Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control · 91d
Cleared Nov 18, 1994
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K944651 · Baxter Diagnostics, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 53d
Cleared Nov 02, 1994
MR7000 WITH TIME MANAGER SOFTWARE (TMS)
K934111 · Dynatech Laboratories, Inc.
JQP · Calculator/data Processing Module, For Clinical Use · 456d
Cleared Nov 02, 1994
SAS SALMONELLA H D ANTISERUM
K943400 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 111d
Cleared Oct 31, 1994
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR
K940979 · Gen-Probe, Inc.
LSL · Dna-reagents, Neisseria · 244d

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All categories 5934 JWY Manual Antimicrobial Susceptibility Test Systems 408 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 75