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
2926–2950 of 5934
Cleared Feb 03, 1994
IMMUNOCARD ROTAVIRUS
K933587 · Meridian Diagnostics, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 192d
Cleared Jan 27, 1994
PASCO MIC PANELS/ GENT & STREP SYNERGY
K934380 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 141d
Cleared Dec 27, 1993
PASCO MIC AND MIC/ID PANELS
K933709 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 150d
Cleared Dec 27, 1993
PASCO MIC AND MIC/ID PANELS
K933746 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 146d
Cleared Dec 22, 1993
DRYSLIDE CEFIN
K930702 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 315d
Cleared Dec 21, 1993
THAYER MARTIN, MODIFIED PILL POCKET
K934331 · Hardy Diagnostics
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 109d
Cleared Dec 17, 1993
TRANSGROW
K934330 · Hardy Diagnostics
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 105d
Cleared Dec 15, 1993
MARTIN LEWIS WITH LINOCMYCIN
K931864 · Hardy Diagnostics
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 245d
Cleared Dec 15, 1993
PYR TEST KIT
K931865 · Hardy Diagnostics
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 245d
Cleared Dec 02, 1993
STREP A NEGATIVE CONTROL
K924461 · Pacific Biotech, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 456d
Cleared Nov 22, 1993
REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK
K934100 · Remel Co.
JTN · Susceptibility Test Discs, Antimicrobial · 91d
Cleared Nov 16, 1993
PASCO MIC AND MIC/ID PANELS
K933849 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 103d
Cleared Nov 05, 1993
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
K931443 · Ortho Diagnostic Systems, Inc.
LSE · Epstein-barr Virus, Other · 228d
Cleared Nov 05, 1993
VISI-SPOT
K932752 · J.S. Medical Assoc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 170d
Cleared Oct 28, 1993
BACTICARD STREP
K933514 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 100d
Cleared Oct 28, 1993
REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK
K933657 · Remel Co.
JTN · Susceptibility Test Discs, Antimicrobial · 93d
Cleared Oct 12, 1993
SYNERGY SCREEN TEST, MODIFICATION
K921977 · Baxter Healthcare Corp
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 539d
Cleared Sep 30, 1993
SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT
K926090 · Syva Co.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 302d
Cleared Sep 30, 1993
TECHLAB 1-HOUR TOX-A-TEST
K931129 · Techlab, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 209d
Cleared Sep 24, 1993
GC II AGAR WITH ISOVITALEX
K932882 · Becton Dickinson Microbiology Systems
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 102d
Cleared Sep 23, 1993
ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
K926002 · Alamar Biosciences Laboratory, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 300d
Cleared Sep 21, 1993
G C II AGAR WITH SENSIVITALEX
K932879 · Becton Dickinson Microbiology Systems
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 99d
Cleared Aug 31, 1993
READAR
K925951 · Alamar Biosciences Laboratory, Inc.
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 280d
Cleared Aug 18, 1993
PASCO MIC AND MIC/ID PANELS
K932917 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 63d
Cleared Aug 10, 1993
UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG
K924689 · United Biotech, Inc.
LYR · Helicobacter Pylori · 327d

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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