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
5928 Microbiology devices
2051–2075 of 5928
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
Cleared Sep 03, 1999
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
K991185 · Zeus Scientific, Inc.
LSR · Reagent, Borrelia Serological Reagent · 148d
Cleared Sep 03, 1999
MUMPS IGG ELISA TEST SYSTEM
K991274 · Columbia Bioscience, Inc.
LJY · Enzyme Linked Immunoabsorbent Assay, Mumps Virus · 143d
Cleared Sep 03, 1999
PASCO MIC AND MIC/ID PANELS (OFLOXACIN)
K992077 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 74d
Cleared Sep 03, 1999
PASCO MIC AND MIC/ID PANELS (CEFEPIME)
K992108 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 73d
Cleared Sep 03, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K992166 · Zeus Scientific, Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 70d
Cleared Sep 03, 1999
PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN
K992297 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 58d
Cleared Sep 03, 1999
BACTALERT FA
K992400 · Organon Teknika Corp.
MDB · System, Blood Culturing · 46d
Cleared Sep 03, 1999
BACT/ALERT PF
K992401 · Organon Teknika Corp.
MDB · System, Blood Culturing · 46d
Cleared Aug 30, 1999
PASCO MIC AND MIC/ID PANELS
K992059 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 73d
Cleared Aug 30, 1999
PASCO MIC AND MIC/ID PANELS (CEFUROXIME)
K992076 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 70d
Cleared Aug 27, 1999
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
K991726 · Binax, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 99d

Looking for a specific microbiology device? Search by device name, K-number or manufacturer.

Search all Microbiology 510(k) devices

Filter by Product Code

All categories 5928 JWY Manual Antimicrobial Susceptibility Test Systems 407 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 74