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
826–850 of 7095
Cleared Mar 17, 2017
Elecsys CMV IgM
K163569 · Roche Diagnostics
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 88d
Cleared Mar 14, 2017
HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
K170127 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 60d
Cleared Mar 14, 2017
FilmArray Warrior Control Panel M290
K163522 · Maine Molecular Quality Controls, Inc.
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 89d
Cleared Mar 14, 2017
Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL
K163517 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 89d
Cleared Mar 13, 2017
VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)
K163563 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 84d
Cleared Mar 06, 2017
Greiner Vacuette Urine Count and Culture, Mannitol tube
K163436 · Greiner Bio-One Na, Inc.
JSM · Culture Media, Non-propagating Transport · 89d
Cleared Feb 23, 2017
VIDAS B.R.A.H.M.S. PCT (PCT)
K162827 · bioMerieux, Inc.
PRI · Procalcitonin Assay · 139d
Not Cleared Feb 23, 2017
Accelerate Pheno system, Accelerate Phenotest BC Kit
DEN160032 · Accelerate Diagnotics
PRH · Positive Blood Culture Identification And Ast Kit · 227d
Cleared Feb 22, 2017
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL
K163298 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 92d
Cleared Feb 22, 2017
Sofia RSV FIA on Sofia 2 analyzer
K162911 · Quidel Corporation
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 128d
Cleared Feb 21, 2017
TRU Legionella
K163273 · Meridian Bioscience, Inc.
MJH · Legionella, Spp., Elisa · 92d
Cleared Feb 17, 2017
SeptiCyte LAB
K163260 · Immunexpress, Inc.
PRE · Rt-qpcr Assay For Mrna Transcript Immune Biomarkers · 88d
Cleared Feb 16, 2017
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
K161437 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 268d
Cleared Feb 14, 2017
Simplexa C. difficile Direct
K163085 · Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
OZN · C. Difficile Toxin Gene Amplification Assay · 103d
Not Cleared Feb 14, 2017
FilmArray NGDS Warrior Panel
DEN160048 · Biofire Defense, LLC
PRD · 120d
Cleared Feb 13, 2017
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
K162456 · Cepheid
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 164d
Cleared Feb 13, 2017
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
K161510 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 257d
Cleared Feb 09, 2017
cobas® CT/NG v2.0 Test
K163184 · Roche Molecular Systems, Inc.
LSL · Dna-reagents, Neisseria · 87d
Cleared Feb 09, 2017
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
K162331 · Cepheid
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 174d
Cleared Feb 09, 2017
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
K161810 · Becton Dickinson
MDB · System, Blood Culturing · 223d
Not Cleared Feb 06, 2017
Variola virus Real-Time PCR Assay
DEN160016 · Centers For Disease Control and Prevention (Cdc)
PRA · Variola Virus Nucleic Acid-based Detection Assay · 298d
Cleared Feb 01, 2017
Lyme B. burgdorferi (IgG) MarStripe Test
K163095 · Trinity Biotech
LSR · Reagent, Borrelia Serological Reagent · 89d
Cleared Feb 01, 2017
VITEK 2 AST-GN Tobramycin (/= 16 ug/mL)
K163083 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 90d
Cleared Jan 27, 2017
chromID Strepto B agar
K163042 · bioMerieux, Inc.
PQZ · Gbs Culture Media, Selective And Differential · 88d
Cleared Jan 24, 2017
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
K163006 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 88d

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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