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
2551–2575 of 7095
Cleared Apr 14, 1997
DISPENS-O-DISC (TM) LEVOFLOXACIN
K971120 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 18d
Cleared Apr 14, 1997
DISPENS-O-DISC SPARFLOXACIN
K971211 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 18d
Cleared Apr 08, 1997
VIDAS C. DIFFICILE TOXIN A II ASSAY
K964887 · Biomerieux Vitek, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 123d
Cleared Apr 08, 1997
IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
K970227 · Dpc Cirrus
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 81d
Cleared Apr 02, 1997
IMMULITE RUBELLA IGG
K963613 · Diagnostic Products Corp.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 204d
Cleared Apr 02, 1997
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
K970830 · Remel, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 26d
Cleared Apr 02, 1997
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
K970831 · Remel, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 26d
Cleared Apr 02, 1997
INDOLE SWAB
K970833 · Remel, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 26d
Cleared Mar 26, 1997
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
K965129 · Wampole Laboratories
LSR · Reagent, Borrelia Serological Reagent · 93d
Cleared Mar 26, 1997
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K965131 · Wampole Laboratories
LSR · Reagent, Borrelia Serological Reagent · 93d
Cleared Mar 24, 1997
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
K954301 · Abbott Laboratories
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 579d
Cleared Mar 24, 1997
TOXO IGG ELISA TEST
K962343 · Gull Laboratories, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 279d
Cleared Mar 24, 1997
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION)
K970597 · Medical Packaging Corp.
JSM · Culture Media, Non-propagating Transport · 34d
Cleared Mar 19, 1997
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
K965190 · Accumed Intl., Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 85d
Cleared Mar 18, 1997
RSV ANTIGEN CONTROL SLIDES
K964870 · Viral Antigens, Inc.
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 103d
Cleared Mar 18, 1997
VZV ANTIGEN CONTROL SLIDES
K964872 · Viral Antigens, Inc.
GQW · Antigen, Cf, (including Cf Control), Varicella-zoster · 103d
Cleared Mar 18, 1997
CMV ANTIGEN CONTROL SLIDES
K964875 · Viral Antigens, Inc.
GQH · Antigen, Cf (including Cf Control), Cytomegalovirus · 103d
Cleared Mar 10, 1997
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
K970100 · Simplicity Diagnostics, Inc.
MJX · Kit, Serological, Positive Control · 59d
Cleared Mar 10, 1997
EPISCREEN
K970357 · Epitope, Inc.
PJD · Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device · 39d
Cleared Mar 10, 1997
SPARFLOZACIN, 5 MCG, SENSI-DISC
K970385 · Becton Dickinson Microbiology Systems
JTN · Susceptibility Test Discs, Antimicrobial · 35d
Cleared Mar 06, 1997
LEVOFLOXACIN, 5MCG, SENSI-DISC
K970212 · Becton Dickinson Microbiology Systems
JTN · Susceptibility Test Discs, Antimicrobial · 44d
Cleared Mar 03, 1997
LEGIONELLA IGG/IGM ELISA TEST SYSTEM
K963318 · Armkel, LLC
LHL · Reagents, Antibody, Legionella, Direct & Indirect Fluorescent · 192d
Cleared Mar 03, 1997
KENLOR H. PYLORI CONTROL SERUM
K964014 · Kenlor Industries, Inc.
LYR · Helicobacter Pylori · 147d
Cleared Feb 24, 1997
CHLAMYDIA IGG ELISA TEST SYSTEM
K962558 · Armkel, LLC
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 238d
Cleared Feb 20, 1997
HEMAGEN CMV IGG KIT
K944438 · Hemagen Diagnostics, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 892d

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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