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

7061
Total
6999
Cleared
155d
Avg (2y)
1976
Since
4573 Microbiology devices
751–775 of 4573
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 Feb 23, 2017
VIDAS B.R.A.H.M.S. PCT (PCT)
K162827 · bioMerieux, Inc.
PRI · Procalcitonin Assay · 139d
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 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 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 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
Cleared Jan 12, 2017
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
K161217 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 258d
Cleared Jan 06, 2017
LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
K162969 · DiaSorin, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 74d
Cleared Jan 05, 2017
LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set
K162961 · DiaSorin, Inc.
LSE · Epstein-barr Virus, Other · 73d
Cleared Jan 04, 2017
LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
K162959 · DiaSorin, Inc.
LSE · Epstein-barr Virus, Other · 72d
Cleared Dec 19, 2016
Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml
K162854 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 68d
Cleared Nov 28, 2016
Solana HSV 1+2/VZV Assay
K162451 · Quidel Corporation
PGI · Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples · 88d
Cleared Nov 23, 2016
Xpert MRSA NxG
K162444 · Cepheid
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 84d
Cleared Nov 15, 2016
HardyCHROM ESBL
K160512 · Hardy Diagnostics
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 265d
Cleared Oct 25, 2016
Solana Strep Complete Assay
K162274 · Quidel Corporation
PGX · Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System · 74d
Cleared Oct 25, 2016
chromID MRSA
K162076 · bioMerieux, Inc.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 90d
Cleared Oct 13, 2016
ADVIA Centaur HAV IgM Assay
K161964 · Siemens Healthcare Diagnostics, Inc.
LOL · Hepatitis A Test (antibody And Igm Antibody) · 87d

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All categories 4573 JWY Manual Antimicrobial Susceptibility Test Systems 361 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 282 JTN Susceptibility Test Discs, Antimicrobial 276 JSJ Culture Media, Selective And Non-differential 232 JSI Culture Media, Selective And Differential 175 JSG Culture Media, Non-selective And Non-differential 168 JTO Discs, Strips And Reagents, Microorganism Differentiation 144 JSH Culture Media, Non-selective And Differential 98 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 75 GRM Antisera, All Groups, Salmonella Spp. 66 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 62 GTZ Antisera, All Groups, Streptococcus Spp. 59 JSF Culture Media, Single Biochemical Test 58 MDB System, Blood Culturing 54 GNC Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. 51