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
5939 Microbiology devices
3376–3400 of 5939
Cleared Jan 22, 1990
VENTRESIGN STREP A TEST
K897083 · Ventrex Laboratories, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 33d
Cleared Jan 16, 1990
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A
K893579 · Whittaker Bioproducts, Inc.
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 252d
Cleared Jan 16, 1990
EBV VCA ANTIBODY (IGM)
K896594 · Hillcrest Biologicals
LJN · Antibody Igm, If, Epstein-barr Virus · 56d
Cleared Jan 11, 1990
WELLCOLEX COLOUR SHIGELLA TEST ZC51
K895461 · Wellcome Diagnostics
GNB · Antisera, All Types, Shigella Spp. · 127d
Cleared Jan 02, 1990
KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)
K895505 · Eastman Kodak Company
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 113d
Cleared Jan 02, 1990
CEFMATZOLE 30 MCG SENSI DISC
K895679 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 104d
Cleared Jan 02, 1990
AUTOSCEPTOR
K896447 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 54d
Cleared Dec 29, 1989
ORTHO* RUBELLA-G ANTIBODY ELISA TEST
K896479 · Ortho Diagnostic Systems, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 46d
Cleared Dec 21, 1989
PLATELIA RUBELLA IGG KIT
K894946 · Kallestad Diag, A Div. of Erbamont, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 140d
Cleared Dec 18, 1989
DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST
K893200 · Gull Laboratories, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 236d
Cleared Dec 18, 1989
DETECTADOT TM SYSTEM 2000 CMV IGM TEST
K893230 · Gull Laboratories, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 234d
Cleared Dec 18, 1989
DIFCO OXIDASE DRYSLIDE
K896398 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 42d
Cleared Dec 13, 1989
HAEMOPHILUS TEST MEDIUM (HTM)AGAR
K894216 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 177d
Cleared Dec 13, 1989
LYME IGG ELISA TEST SYSTEM
K895292 · Zeus Scientific, Inc.
LSR · Reagent, Borrelia Serological Reagent · 110d
Cleared Dec 13, 1989
CARDS O.S.(TM) STREP A
K896221 · Pacific Biotech, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 44d
Cleared Dec 11, 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
K895708 · Immuno Concepts, Inc.
LLM · Test, Antigen, Nuclear, Epstein-barr Virus · 77d
Cleared Dec 08, 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)
K895707 · Immuno Concepts, Inc.
LLM · Test, Antigen, Nuclear, Epstein-barr Virus · 74d
Cleared Dec 01, 1989
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST
K895362 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTT · Susceptibility Test Powders, Antimicrobial · 94d
Cleared Nov 30, 1989
IFA SENSIBAC CEFACLOR
K892721 · Investigacion Farmaceutica S.A. DE C.V.
JTN · Susceptibility Test Discs, Antimicrobial · 230d
Cleared Nov 29, 1989
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION
K895103 · Gen-Probe, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 106d
Cleared Nov 29, 1989
IMMUNOCARD STREP A TEST
K896109 · Disease Detection International, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 37d
Cleared Nov 17, 1989
IDEIA HERPES SIMPLEX VIRUS TEST
K871877 · Boots-Celltech Diagnostics, Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 918d
Cleared Nov 17, 1989
OLYMPUS PK(TM) TP
K893124 · Fujirebio Diagnostics,Inc.
GMT · Antigens, Ha, Treponema Pallidum · 206d
Cleared Nov 14, 1989
ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.
K894711 · Gen-Probe, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 111d
Cleared Nov 14, 1989
ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION
K894712 · Gen-Probe, Inc.
LQO · Dna-reagents, Campylobacter Spp. · 111d

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All categories 5939 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 99 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