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
2201–2225 of 7095
Cleared Nov 02, 1999
SERAQUEST EB NA IGG
K991975 · Quest Intl., Inc.
LSE · Epstein-barr Virus, Other · 144d
Cleared Nov 02, 1999
PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN
K992717 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 82d
Cleared Oct 28, 1999
SERAQUEST EB VCA IGG
K990410 · Quest Intl., Inc.
LSE · Epstein-barr Virus, Other · 261d
Cleared Oct 25, 1999
HYBRID CAPTURE II CT-ID TEST
K990023 · Digene Corp.
LSK · Dna-reagents, Chlamydia · 293d
Cleared Oct 19, 1999
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
K990141 · Light Diagnostics
GQW · Antigen, Cf, (including Cf Control), Varicella-zoster · 273d
Cleared Oct 19, 1999
PASCO MIC AND MIC/ID PANELS, PENICILLIN
K992646 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 74d
Cleared Oct 19, 1999
PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN
K992647 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 74d
Cleared Oct 14, 1999
PASCO MIC AND MIC/ID PANELS, CEFOTAXIME
K992568 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 73d
Cleared Oct 14, 1999
PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL
K992593 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 72d
Cleared Oct 13, 1999
PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE
K992562 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 72d
Cleared Oct 12, 1999
PASCO MIC AND MIC/ID PANELS, MEROPENEM
K992546 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 74d
Cleared Oct 08, 1999
PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN
K992507 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 73d
Cleared Oct 06, 1999
SERAQUEST EB VAC IGM
K990977 · Quest Intl., Inc.
LJN · Antibody Igm, If, Epstein-barr Virus · 197d
Cleared Sep 27, 1999
MODIFICATION OF PASCO MIC AND MIC/ID PANELS
K992420 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 68d
Cleared Sep 24, 1999
EZ-HBT HELICOBACTER BLOOD TEST
K990931 · Metabolic Solutions, Inc.
MSQ · Test, Urea (breath Or Blood) · 189d
Cleared Sep 24, 1999
QUICKVUE INFLUENZA A/B TEST
K991633 · Quidel Corp.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 135d
Cleared Sep 24, 1999
BACT/ALERT FN
K992432 · Organon Teknika Corp.
MDB · System, Blood Culturing · 65d
Cleared Sep 21, 1999
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
K991062 · Immunetics, Inc.
LSR · Reagent, Borrelia Serological Reagent · 174d
Cleared Sep 21, 1999
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024
K991063 · Immunetics, Inc.
LSR · Reagent, Borrelia Serological Reagent · 174d
Cleared Sep 21, 1999
PASCO MIC AND MIC/ID PANELS, VANCOMYCIN
K992296 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 76d
Cleared Sep 20, 1999
AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI
K992124 · Avanti Polar Lipids, Inc.
GMQ · Antigens, Nontreponemal, All · 89d
Cleared Sep 16, 1999
MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)
K992143 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 84d
Cleared Sep 15, 1999
NUCLISENS CMV PP67
K983762 · Organon Teknika Corp.
LIN · Antisera, Conjugated Fluorescent, Cytomegalovirus · 324d
Cleared Sep 03, 1999
IS H. PYLORI IGG ELISA TEST SYSTEM
K990462 · Columbia Bioscience, Inc.
LYR · Helicobacter Pylori · 203d
Cleared Sep 03, 1999
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
K991180 · Zeus Scientific, Inc.
LSR · Reagent, Borrelia Serological Reagent · 148d

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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