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
3076–3100 of 5934
Cleared Jul 28, 1992
CEFZIL
K922793 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 49d
Cleared Jul 28, 1992
ENOXACIN
K922794 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 49d
Cleared Jul 23, 1992
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
K921435 · Gen-Probe, Inc.
LQF · Dna-reagents, Mycobacterium Spp. · 120d
Cleared Jul 22, 1992
ABBOTT STREP A CONTROLS
K922490 · Abbott Laboratories
GTY · Antigens, All Groups, Streptococcus Spp. · 56d
Cleared Jul 16, 1992
TESTPACK PLUS STREP A
K922345 · Abbott Laboratories
GTZ · Antisera, All Groups, Streptococcus Spp. · 58d
Cleared Jul 14, 1992
ESP BLOOD CULTURE SYSTEM
K921637 · Difco Laboratories, Inc.
MDB · System, Blood Culturing · 99d
Cleared Jul 10, 1992
PREMIER COCCIDIOIDES
K915493 · Meridian Diagnostics, Inc.
MIY · Enzyme Linked Immunosorbent Assay, Coccidioides Immitis · 214d
Cleared Jul 01, 1992
BACTEC 9120 SYSTEM
K922475 · Bd Becton Dickinson Vacutainer Systems Preanalytic
MDB · System, Blood Culturing · 36d
Cleared Jun 29, 1992
MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM
K921556 · Medical Diagnostic Technologies, Inc.
LJZ · Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. · 89d
Cleared Jun 22, 1992
MODIFIED ORTHO EBV VCA-IGG ELISA
K920412 · Ortho Diagnostic Systems, Inc.
MCD · Antigen, Ebv, Capsid · 143d
Cleared Jun 19, 1992
BACTIDROP INDOLE (ERLICH'S)
K920973 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 109d
Cleared Jun 19, 1992
BACTIDROP ACRIDINE ORANGE
K920974 · Remel Co.
JFO · Fluorometric, Calcium · 109d
Cleared Jun 19, 1992
DRYSLIDE(TM), PYR
K921583 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 102d
Cleared Jun 09, 1992
TB SUSCEPTIBILITY QUADS I AND II
K920143 · Remel Co.
MJD · Culture Media, Antimycobacteria, Susceptibility Test · 148d
Cleared May 22, 1992
AUTOSCEPTOR IDENTIFICATION SYSTEM
K920225 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LRH · Instrument For Auto Reader Of Overnight Microorganism Identification System · 126d
Cleared May 22, 1992
BACTIDROP NINHYDRIN
K920971 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 81d
Cleared May 22, 1992
BACTIDROP PYR
K920972 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 81d
Cleared May 08, 1992
AZITHROMYCIN, 15 MCG, SENSI DISC
K921420 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 45d
Cleared May 06, 1992
MAXAQUIN
K921282 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 50d
Cleared May 04, 1992
CHAGAS' IGG ELISA TEST
K911233 · Gull Laboratories, Inc.
MIU · Enzyme Linked Immunosorbent Assay, T. Cruzi · 411d
Cleared May 04, 1992
RUBALEX, MODIFICATION
K912391 · Orion Corp.
LQN · Latex Agglutination Assay, Rubella · 346d
Cleared May 04, 1992
CAPTIA CMV-TA
K915479 · Mercia Diagnostics , Ltd.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 150d
Cleared Apr 29, 1992
ENZYGNOST(R) TOXOPLASMOSIS/IGG
K913731 · Behring Diagnostics, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 253d
Cleared Apr 29, 1992
PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
K920378 · Gen-Probe, Inc.
LSK · Dna-reagents, Chlamydia · 91d
Cleared Apr 28, 1992
ENZYGNOST(R) ANTI-CMV IGG
K913910 · Behring Diagnostics, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 242d

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