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
1401–1425 of 7095
Cleared Apr 15, 2009
ORTHO T. CRUZI ELISA TEST SYSTEM
K072732 · Ortho-Clinical Diagnostics, Inc.
MIU · Enzyme Linked Immunosorbent Assay, T. Cruzi · 567d
Cleared Apr 08, 2009
AVC A/H5N1 FLU TEST
K083278 · Arbor Vita Corportation
OMS · Novel Influenza A Virus, A/h5 Ns1 Protein · 152d
Cleared Apr 01, 2009
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
K081527 · Millipore Corporation
GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2 · 303d
Cleared Mar 26, 2009
EK/P. AERUGINOSA PNA FISH
K081433 · Advandx, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 309d
Cleared Mar 26, 2009
C. DIFF QUIK CHEK COMPLETE
K082499 · Techlab, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 209d
Cleared Mar 24, 2009
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
K083606 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 109d
Cleared Mar 16, 2009
VITEK 2 GRAM NEGATIVE DORIPENEM
K082346 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 213d
Cleared Mar 06, 2009
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K081063 · Trek Diagnostic Systems, Inc.
NGZ · Susceptibility Test Plate, Antifungal · 326d
Cleared Mar 06, 2009
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
K090073 · Diagnostic Hybrids, Inc.
OMG · Antisera, Fluorescent, Human Metapneumovirus · 53d
Cleared Feb 23, 2009
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
K080008 · Bio-Rad Laboratories, Inc.
OMI · Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv · 418d
Cleared Feb 18, 2009
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)
K083262 · Siemens Healthcare Diagnostics
LTT · Panels, Test, Susceptibility, Antimicrobial · 105d
Cleared Feb 18, 2009
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K083383 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 93d
Cleared Feb 12, 2009
ELECSYS TOXO IGG CALCHECK
K083655 · Roche Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 64d
Cleared Jan 30, 2009
PREMIER CAMPY, MODEL 618096
K083464 · Meridian Bioscience, Inc.
LQP · Campylobacter Spp. · 67d
Cleared Jan 29, 2009
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML
K082852 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 122d
Cleared Jan 15, 2009
REAL-TIME PCR INTERNAL CONTROL 2B SET
K083430 · Nanogen, Inc.
OLD · Internal Polymerase Chain Reaction Control, Not Assay Specific · 57d
Cleared Jan 14, 2009
GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
K081064 · Ivd Research, Inc.
MHI · Giardia Spp. · 275d
Cleared Dec 30, 2008
VIROCULT, MODEL MW950
K082472 · Medical Wire & Equipment Company (Bath), Ltd.
LIO · Device, Specimen Collection · 124d
Cleared Dec 24, 2008
BD BACTEC Plus Aerobic/F Culture Vials
K083572 · Becton, Dickinson & CO
MDB · System, Blood Culturing · 21d
Cleared Dec 23, 2008
VIDAS RUB IGG
K080766 · bioMerieux, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 280d
Cleared Dec 23, 2008
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
K081746 · Diagnostic Hybrids, Inc.
GNW · Antisera, Cf, Influenza Virus A, B, C · 187d
Cleared Dec 23, 2008
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
K081928 · Diagnostic Hybrids, Inc.
LKT · Respiratory Syncytial Virus, Antigen, Antibody, Ifa · 169d
Cleared Dec 19, 2008
E.COLI/P. AERUGINOSA PNA FISH
K081309 · Advandx, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 224d
Cleared Dec 19, 2008
BD GENEOHM CDIFF ASSAY
K081920 · Bd Diagnostics (Geneohm Sciences, Inc.)
LLH · Reagents, Clostridium Difficile Toxin · 169d
Cleared Dec 11, 2008
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K081824 · Becton, Dickinson & CO
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 167d

Looking for a specific microbiology device? Search by device name, K-number or manufacturer.

Search all Microbiology 510(k) devices

Filter by Product Code

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