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
876–900 of 7095
Cleared Aug 25, 2016
LIAISON HAV IgM, LIAISON Control HAV IgM
K160650 · DiaSorin, Inc.
LOL · Hepatitis A Test (antibody And Igm Antibody) · 170d
Cleared Aug 18, 2016
Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
K161375 · Alere Scarborough, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 92d
Cleared Aug 15, 2016
Solana Trichomonas Assay
K161182 · Quidel Corporation
OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System · 110d
Cleared Aug 12, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgM)
K153308 · Euroimmun Us, Inc.
NOP · Elisa, Antibody, West Nile Virus · 269d
Cleared Aug 10, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgG)
K153303 · Euroimmun Us, Inc.
NOP · Elisa, Antibody, West Nile Virus · 268d
Cleared Aug 08, 2016
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
K161306 · Becton Dickinson
MDB · System, Blood Culturing · 90d
Cleared Aug 02, 2016
ARIES® Flu A/B & RSV Assay
K161220 · Luminex Corporation
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 95d
Cleared Jul 29, 2016
Puritan Opti-Tranz Cary-Blair Collection and Transport System
K160082 · Puritan Medical Products, LLC
JSM · Culture Media, Non-propagating Transport · 196d
Cleared Jul 28, 2016
Elecsys Syphilis
K160910 · Roche Diagnostics
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 118d
Cleared Jul 25, 2016
cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
K153544 · Iquum, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 227d
Cleared Jul 22, 2016
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
K161139 · DiaSorin, Inc.
LYR · Helicobacter Pylori · 91d
Cleared Jul 20, 2016
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
K161227 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 79d
Cleared Jul 12, 2016
Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL
K161175 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 77d
Cleared Jul 05, 2016
Lumipulse G TP-N Immunoreaction Cartridge Set
K153145 · Fujirebio Diagnostics,Inc.
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 249d
Cleared Jun 30, 2016
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit
K161556 · Centers For Disease Control and Prevention (Cdc)
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 24d
Cleared Jun 30, 2016
LIAISON CMV IgM Serum Control Set
K161526 · DiaSorin, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 28d
Cleared Jun 30, 2016
LIAISON EBV IgM Serum Control Set
K161522 · DiaSorin, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 28d
Cleared Jun 30, 2016
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
K161495 · Luminex Corporation
OOI · Real Time Nucleic Acid Amplification System · 29d
Cleared Jun 29, 2016
Xpert Carba-R
K160901 · Cepheid
POC · System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen · 89d
Cleared Jun 28, 2016
VIDAS B.R.A.H.M.S. PCT (PCT)
K160911 · bioMerieux, Inc.
PMT · Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens · 88d
Cleared Jun 22, 2016
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
K153569 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 190d
Cleared Jun 15, 2016
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
K153730 · Abbott Laboratories
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 170d
Cleared Jun 13, 2016
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
K160829 · Meridian Bioscience, Inc.
OZX · Mycoplasma Pneumoniae Dna Assay System · 80d
Cleared Jun 13, 2016
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
K160729 · Roche Diagnostics
PMT · Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens · 89d
Cleared May 13, 2016
SeraQuest HSV Type 2 Specific IgG
K152353 · Quest International, Inc.
MYF · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 · 267d

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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