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
2626–2650 of 7095
Cleared Oct 17, 1996
INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
K960434 · Incstar Corp.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 260d
Cleared Oct 15, 1996
HAEMOPHILUS TEST MEDIUM AGAR (HTM)
K962744 · Prepared Media Laboratory, Inc.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 92d
Cleared Oct 11, 1996
OSOM STREP A TEST
K961423 · Wyntek Diagnostics, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 182d
Cleared Oct 09, 1996
OPUS CMV TEST SYSTEM-MODIFICATION
K963084 · Behring Diagnostics, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 62d
Cleared Oct 08, 1996
ETEST SUBMISSION FOR AMOXICILLIN
K960991 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 211d
Cleared Oct 08, 1996
IDS RAPID CB PLUS SYSTEM
K962966 · Innovative Diagnostic Systems, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 70d
Cleared Oct 07, 1996
VIDAS CHLAMYDIA BLOCKING ASSAY
K955627 · Biomerieux Vitek, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 301d
Cleared Oct 07, 1996
EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT
K962146 · Excel Scientific, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 126d
Cleared Oct 07, 1996
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
K963036 · Becton Dickinson Microbiology Systems
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 63d
Cleared Oct 02, 1996
ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)
K962745 · Prepared Media Laboratory, Inc.
JSN · Culture Media, Propagating Transport · 79d
Cleared Sep 30, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K962867 · Sensititre Alamar
JWY · Manual Antimicrobial Susceptibility Test Systems · 69d
Cleared Sep 26, 1996
DISPENS-O-DISC MEROPENEM
K963508 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 23d
Cleared Sep 24, 1996
AXSYM RUBELLA IGG ANTIBODY ASSAY
K954045 · Abbott Laboratories
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 392d
Cleared Sep 20, 1996
AXSYM CMV IGG ANTIBODY ASSAY
K953943 · Abbott Laboratories
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 396d
Cleared Sep 18, 1996
GONOPOX TEST KIT
K960759 · Medtex Laboratories, Inc.
JSX · Kit, Identification, Neisseria Gonorrhoeae · 205d
Cleared Sep 18, 1996
10B ARGININE BROTH
K961046 · Remel, L.P.
JSM · Culture Media, Non-propagating Transport · 187d
Cleared Sep 18, 1996
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K962843 · Starplex Scientific, Inc.
JSM · Culture Media, Non-propagating Transport · 58d
Cleared Sep 17, 1996
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
K952220 · Meretek Diagnostics, Inc.
LYR · Helicobacter Pylori · 495d
Cleared Sep 13, 1996
CLEARVIEW C. DIFF A
K955067 · Unipath , Ltd.
MCB · Antigen, C. Difficile · 312d
Cleared Sep 05, 1996
ELVIS HSV GOLD
K960578 · Diagnostic Hybrids, Inc.
GQN · Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 · 206d
Cleared Sep 04, 1996
SERAQUEST RUBELLA IGG
K961053 · Quest Intl., Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 170d
Cleared Aug 30, 1996
VARELISA HELICOBACTER PYLORI ANTIBODIES
K953873 · Elias U.S.A., Inc.
LYR · Helicobacter Pylori · 379d
Cleared Aug 30, 1996
E. HISTOLYTICA TEST
K955895 · Techlab, Inc.
KHW · Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. · 248d
Cleared Aug 30, 1996
GRAM NEGATIVE IDENTIFICATION PLUS CARD
K962609 · Biomerieux Vitek, Inc.
LRH · Instrument For Auto Reader Of Overnight Microorganism Identification System · 58d
Cleared Aug 30, 1996
ETEST FOR AZTREONAM
K962794 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 44d

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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