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
5928 Microbiology devices
2026–2050 of 5928
Cleared Dec 09, 1999
MICROSTREP PLUS PANEL
K983746 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 412d
Cleared Dec 02, 1999
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K993102 · Dade Microscan, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 77d
Cleared Dec 01, 1999
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974503 · Roche Molecular Systems, Inc.
LSL · Dna-reagents, Neisseria · 733d
Cleared Dec 01, 1999
CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC
K993577 · Becton Dickinson Microbiology Systems
JTN · Susceptibility Test Discs, Antimicrobial · 41d
Cleared Nov 29, 1999
HYBRID CAPTURE II GC-ID
K981485 · Digene Corp.
LSL · Dna-reagents, Neisseria · 584d
Cleared Nov 23, 1999
SIRSCAN
K991473 · Intelligence Artificielle Applications
KZK · Reader, Zone, Automated · 210d
Cleared Nov 16, 1999
ETEST FOR QUINUPRISTIN/DALFOPRISTIN
K992993 · Ab Biodisk
LTX · Discs, Elution · 70d
Cleared Nov 09, 1999
LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
K991880 · Light Diagnostics
GQN · Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 · 160d
Cleared Nov 09, 1999
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
K993161 · Copan Diagnostics, Inc.
JTW · System, Transport, Aerobic · 48d
Cleared Nov 04, 1999
BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
K984631 · Becton Dickinson Microbiology Systems
LSL · Dna-reagents, Neisseria · 309d
Cleared Nov 04, 1999
PASCO MIC AND MIC/ID PANELS, CEFDINIR
K992853 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 72d
Cleared Nov 03, 1999
PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS
K992726 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 82d
Cleared Nov 03, 1999
SYNERCID, 15 UG, BBL SENSI-DISC
K993186 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 42d
Cleared Nov 02, 1999
CDTOX A OIA
K991829 · Biostar, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 158d
Cleared Nov 02, 1999
SERAQUEST EB NA IGG
K991975 · Quest Intl., Inc.
LSE · Epstein-barr Virus, Other · 144d
Cleared Nov 02, 1999
PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN
K992717 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 82d
Cleared Oct 28, 1999
SERAQUEST EB VCA IGG
K990410 · Quest Intl., Inc.
LSE · Epstein-barr Virus, Other · 261d
Cleared Oct 25, 1999
HYBRID CAPTURE II CT-ID TEST
K990023 · Digene Corp.
LSK · Dna-reagents, Chlamydia · 293d
Cleared Oct 19, 1999
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
K990141 · Light Diagnostics
GQW · Antigen, Cf, (including Cf Control), Varicella-zoster · 273d
Cleared Oct 19, 1999
PASCO MIC AND MIC/ID PANELS, PENICILLIN
K992646 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 74d
Cleared Oct 19, 1999
PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN
K992647 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 74d
Cleared Oct 14, 1999
PASCO MIC AND MIC/ID PANELS, CEFOTAXIME
K992568 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 73d
Cleared Oct 14, 1999
PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL
K992593 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 72d
Cleared Oct 13, 1999
PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE
K992562 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 72d
Cleared Oct 12, 1999
PASCO MIC AND MIC/ID PANELS, MEROPENEM
K992546 · Pasco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 74d

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All categories 5928 JWY Manual Antimicrobial Susceptibility Test Systems 407 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 74