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
1326–1350 of 5928
Cleared Jun 25, 2009
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116
K091667 · Luminex Molecular Diagnostics, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 16d
Cleared Jun 18, 2009
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K091126 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 59d
Cleared Jun 08, 2009
SERAQUEST EBV EA-D IGG TEST
K091260 · Quest Intl., Inc.
LSE · Epstein-barr Virus, Other · 40d
Cleared Jun 05, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090971 · Becton, Dickinson & CO
LSL · Dna-reagents, Neisseria · 60d
Cleared Jun 04, 2009
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K090968 · Trek Diagnostic Systems, Inc.
NGZ · Susceptibility Test Plate, Antifungal · 59d
Cleared Jun 02, 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K090824 · Becton, Dickinson & CO
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 68d
Cleared May 28, 2009
IMMUNOCARD STAT CAMPY, MODEL 751530
K090700 · Meridian Bioscience, Inc.
LQP · Campylobacter Spp. · 72d
Cleared May 27, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090827 · Becton, Dickinson & CO
LSL · Dna-reagents, Neisseria · 62d
Cleared May 08, 2009
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K090409 · Bio-Rad Laboratories
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 79d
Cleared May 05, 2009
GBS PNA FISH
K082612 · Advandx, Inc.
OAH · Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis · 238d
Cleared May 05, 2009
ELECSYS RUBELLA IGG CALCHECK
K090311 · Roche Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 88d
Cleared May 01, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
K083088 · Nanosphere, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 197d
Cleared Apr 15, 2009
ORTHO T. CRUZI ELISA TEST SYSTEM
K072732 · Ortho-Clinical Diagnostics, Inc.
MIU · Enzyme Linked Immunosorbent Assay, T. Cruzi · 567d
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

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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