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
3101–3125 of 5934
Cleared Apr 27, 1992
LOMEFLOXACIN, 10 MCG, SENSI DISC
K921193 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 46d
Cleared Apr 23, 1992
BACT/ALERT PEDI-BACT
K920249 · Organon Teknika Corp.
MDB · System, Blood Culturing · 93d
Cleared Apr 22, 1992
RUBELLA IGM ELISA TEST SYSTEM
K914028 · Zeus Scientific, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 225d
Cleared Apr 22, 1992
ORTHO HSV ANTIGEN ELISA TEST
K915551 · Ortho Diagnostic Systems, Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 133d
Cleared Apr 22, 1992
BACTEC 9240 SYSTEM
K915796 · Bd Becton Dickinson Vacutainer Systems Preanalytic
MDB · System, Blood Culturing · 120d
Cleared Apr 22, 1992
NIACIN CONTROL DISKS
K920257 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 92d
Cleared Apr 22, 1992
BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA
K921133 · Bd Becton Dickinson Vacutainer Systems Preanalytic
MDB · System, Blood Culturing · 43d
Cleared Apr 17, 1992
BACTEC FOS CULTURE SUPPLEMENT
K920933 · Bd Becton Dickinson Vacutainer Systems Preanalytic
MDB · System, Blood Culturing · 49d
Cleared Apr 08, 1992
IMMUNODOT BORRELIA (LYME) TEST
K911627 · General Biometrics, Inc.
LSR · Reagent, Borrelia Serological Reagent · 363d
Cleared Apr 08, 1992
SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB
K920416 · Behring Diagnostics, Inc.
LIB · Device, General Purpose, Microbiology, Diagnostic · 68d
Cleared Apr 08, 1992
LORACARBEF 30MCG, SENSI DISC
K920786 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 48d
Cleared Apr 08, 1992
TEMAFLOXCIN, 5MCG, SENSI DISC
K920787 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 48d
Cleared Apr 02, 1992
ACCUPACE GROUP A STREPTOCOCCUS ID TEST
K915852 · Gen-Probe, Inc.
MDK · Dna-probe, Reagents, Streptococcal · 97d
Cleared Mar 23, 1992
DIRECTIGEN MENINGITIS COMBO TEST KIT
K915330 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GTJ · Antisera, All Groups, N. Meningitidis · 118d
Cleared Mar 23, 1992
CEFPROZIL 30MCG, SENSI DISC
K920473 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 55d
Cleared Mar 23, 1992
BBL STREP GROUPING KIT
K920565 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GTZ · Antisera, All Groups, Streptococcus Spp. · 45d
Cleared Mar 19, 1992
BECKMAN ANTISTREPTOLYSIN O, MODIFICATION
K915053 · Beckman Instruments, Inc.
GTQ · Antistreptolysin - Titer/streptolysin O Reagent · 140d
Cleared Mar 18, 1992
DIRECTIGEN NEISSERIA MENINGITIDIS TEST
K920274 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GTI · Antisera, Fluorescent, All Groups, N. Meningitidis · 56d
Cleared Mar 04, 1992
ENZYGNOST TOXOPLASMOSIS/IGM
K913505 · Behring Diagnostics, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 210d
Cleared Mar 04, 1992
ELISA CMV IGM
K914789 · Sclavo, Inc.
LKQ · Antibody Igm,if, Cytomegalovirus Virus · 133d
Cleared Mar 04, 1992
CLOSTRIDIUM DIFFICILE TOX-A-TEST
K914902 · Techlab, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 124d
Cleared Mar 04, 1992
KALLESTAD ROTAVIRUS MICROPLATE
K915137 · Bio-Rad Laboratories, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 112d
Cleared Mar 04, 1992
VIDAS CHLAMYDIA ASSAY, MODIFICATION
K915884 · Vitek Systems, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 83d
Cleared Mar 04, 1992
TOXO IGG ELISA TEST (MODIFIED)
K915891 · Gull Laboratories, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 71d
Cleared Mar 04, 1992
RUBELLA IGG ELISA TEST
K915893 · Gull Laboratories, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 71d

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