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
2226–2250 of 7095
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
Cleared Aug 26, 1999
PASCO MIC AND MIC/ID PANELS
K991925 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 79d
Cleared Aug 19, 1999
POCKIT HSV 2 RAPID TEST
K983886 · Diagnology , Ltd.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 290d
Cleared Aug 19, 1999
SAS ADENO TEST
K990630 · Sa Scientific, Inc.
GOD · Antigens, Cf (including Cf Control), Adenovirus 1-33 · 174d
Cleared Aug 19, 1999
STREP B OIA
K991828 · Biostar, Inc.
GTY · Antigens, All Groups, Streptococcus Spp. · 83d
Cleared Aug 12, 1999
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
K991820 · Zeus Scientific, Inc.
LYR · Helicobacter Pylori · 77d
Cleared Aug 11, 1999
GONOSTAT GONOCOCCAL DETECTION KIT
K991268 · Sierra Diagnostics
LSL · Dna-reagents, Neisseria · 120d
Cleared Aug 10, 1999
LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
K992252 · Chemicon Intl., Inc.
LYF · Pneumocystis Carinii · 35d
Cleared Aug 09, 1999
IMMUNOCARD STAT! E. COLI O157:H7
K990263 · Meridian Diagnostics, Inc.
GMZ · Antigens, All Types, Escherichia Coli · 194d
Cleared Aug 09, 1999
SAS ROTA TEST
K990842 · Sa Scientific, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 147d
Cleared Aug 04, 1999
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973707 · Roche Molecular Systems, Inc.
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 674d
Cleared Aug 04, 1999
QUICKVUE ONE-STEP H. PYLORI II TEST
K991747 · Quidel Corp.
LYR · Helicobacter Pylori · 75d
Cleared Jul 20, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
K984180 · Zeus Scientific, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 239d
Cleared Jul 13, 1999
ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING
K972772 · Trek Diagnostic Systems, Inc.
MJA · Susceptibility Test Powders, Antimycobacterial · 719d
Cleared Jul 12, 1999
CMV BRITE TURBO KIT
K991650 · Biotest Diagnostics Corp.
LIN · Antisera, Conjugated Fluorescent, Cytomegalovirus · 60d

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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