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
2176–2200 of 7095
Cleared Dec 21, 1999
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
K993812 · Hardy Diagnostics
JSM · Culture Media, Non-propagating Transport · 41d
Cleared Dec 21, 1999
HARDYDISK AZITHROMYCIN 15MCG
K993994 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 27d
Cleared Dec 21, 1999
E. HISTOLYTICA II
K994101 · Techlab, Inc.
KHW · Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. · 15d
Cleared Dec 20, 1999
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
K993048 · Roche Diagnostics Corp.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 101d
Cleared Dec 16, 1999
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · DiaSorin, Inc.
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 139d
Cleared Dec 16, 1999
INTRAY GC
K993033 · Biomed Diagnostics, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 98d
Cleared Dec 16, 1999
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
K993952 · Diagnostic Products Corp.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 24d
Cleared Dec 15, 1999
BACT/ALERT SA
K993423 · Organon Teknika Corp.
MDB · System, Blood Culturing · 64d
Cleared Dec 14, 1999
BACT/ALERT SN
K993421 · Organon Teknika Corp.
MDB · System, Blood Culturing · 63d
Cleared Dec 14, 1999
BACT/ALERT MP PROCESS BOTTLE
K993576 · Organon Teknika Corp.
MDB · System, Blood Culturing · 54d
Cleared Dec 10, 1999
PREMIER TOXINS A&B, MODEL 616096
K993914 · Meridian Diagnostics, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 23d
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

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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