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
2876–2900 of 5934
Cleared Oct 27, 1994
MICROSPORIDIUM CONTROL SET
K943228 · Meridian Diagnostics, Inc.
LJG · Quality Control Slides · 113d
Cleared Oct 27, 1994
GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS
K943407 · Becton Dickinson Microbiology Systems
JTN · Susceptibility Test Discs, Antimicrobial · 105d
Cleared Oct 19, 1994
DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL
K934323 · Baxter Diagnostics, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 411d
Cleared Oct 19, 1994
PASCO MIC AND MIC/ID PANELS
K944517 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 34d
Cleared Oct 04, 1994
BRAIN HEART INFUSION AGAR
K944554 · Carr-Scarborough Microbiologicals, Inc.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 18d
Cleared Sep 20, 1994
IMMUNOCARD MYCOPLASMA
K934550 · Meridian Diagnostics, Inc.
LJZ · Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. · 363d
Cleared Sep 20, 1994
BINAX LEGIONELLA URINARY ANTIGEN EIA
K934965 · Binax, Inc.
MJH · Legionella, Spp., Elisa · 340d
Cleared Sep 20, 1994
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
K935393 · Bio-Rad Laboratories, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 316d
Cleared Sep 19, 1994
REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG
K935975 · Remel, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 280d
Cleared Sep 19, 1994
SYNERGY QUAD
K941443 · Remel Co.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 179d
Cleared Sep 19, 1994
BHI AGAR WITH VANCOMYCIN
K941444 · Remel Co.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 179d
Cleared Aug 30, 1994
BACT/ALERT FAN AEROBIC CULTURE BOTTLE
K935711 · Organon Teknika Corp.
MDB · System, Blood Culturing · 273d
Cleared Aug 24, 1994
MUELLER HINTON AGAR W/OXACILLIN
K941985 · Carr-Scarborough Microbiologicals, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 121d
Cleared Aug 15, 1994
FLEXTRANS
K935987 · Baxter Diagnostics, Inc.
JSM · Culture Media, Non-propagating Transport · 244d
Cleared Aug 02, 1994
VIDAS CMV IGM ASSAY
K933549 · Biomerieux Vitek, Inc.
LKQ · Antibody Igm,if, Cytomegalovirus Virus · 376d
Cleared Jul 28, 1994
STAPHYTECT-OD
K940557 · Unipath , Ltd.
LHJ · Staphylococcus Aureus Protein A Insoluble · 171d
Cleared Jul 18, 1994
MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010
K932482 · Medix Biotech, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 420d
Cleared Jul 18, 1994
QUICKVUE IN-LINE ONE-STEP STREP A TEST
K934484 · Quidel Corp.
GTZ · Antisera, All Groups, Streptococcus Spp. · 307d
Cleared Jul 18, 1994
CHLAMYDIA TRACHOMATIS ANTIGEN TEST
K941714 · Neogenex
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 117d
Cleared Jul 06, 1994
INFLUENZA A ANTIGEN TEST
K942172 · Neogenex
GNW · Antisera, Cf, Influenza Virus A, B, C · 62d
Cleared Jun 30, 1994
DISPENS-O-DISC(TM) NITROCEFIN
K941016 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 119d
Cleared Jun 30, 1994
CMV EARLY ANTIGEN TEST
K942171 · Neogenex
GQI · Antiserum, Cf, Cytomegalovirus · 56d
Cleared Jun 30, 1994
RSV ANTIGEN TEST
K942173 · Neogenex
LKT · Respiratory Syncytial Virus, Antigen, Antibody, Ifa · 56d
Cleared Jun 30, 1994
INFLUENZA B ANITGEN TEST
K942174 · Neogenex
GNW · Antisera, Cf, Influenza Virus A, B, C · 56d
Cleared Jun 28, 1994
OPUS CMV-G
K933389 · Pb Diagnostic Systems, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 351d

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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 OCC Respiratory Virus Panel Nucleic Acid Assay System 75 LYR Helicobacter Pylori 75