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
726–750 of 4573
Cleared Aug 30, 2017
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL
K172274 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 33d
Cleared Aug 01, 2017
HardyDisk AST Delafloxacin 5 µg (DLX5)
K171975 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 32d
Cleared Aug 01, 2017
Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
K171906 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 36d
Cleared Aug 01, 2017
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL
K171870 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 40d
Cleared Jul 22, 2017
VITEK MS
K162950 · bioMerieux, Inc.
PEX · System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates · 271d
Cleared Jul 10, 2017
TRI-COMBO PARASITE SCREEN
K171078 · Techlab, Inc.
MHJ · Cryptosporidium Spp. · 90d
Cleared Jun 23, 2017
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
K162678 · Roche Diagnostics
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 270d
Cleared Jun 21, 2017
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
K162737 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 264d
Cleared Jun 15, 2017
Aptima Herpes Simplex Viruses 1 & 2 Assay
K162673 · Hologic, Inc.
OQO · Herpes Simplex Virus Nucleic Acid Amplification Assay · 262d
Cleared Jun 07, 2017
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
K170772 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 85d
Cleared Jun 07, 2017
E. HISTOLYTICA QUIK CHEK
K170728 · Techlab, Inc.
KHW · Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. · 90d
Cleared May 31, 2017
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
K170670 · bioMerieux, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 86d
Cleared May 25, 2017
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
K170892 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 59d
Cleared May 22, 2017
Strep B Carrot Broth One-Step
K170586 · Hardy Diagnostics
PQZ · Gbs Culture Media, Selective And Differential · 83d
Cleared May 19, 2017
BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
K170509 · Bio-Rad Laboratories
PUQ · Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm · 87d
Cleared May 16, 2017
Strep B Carrot Broth Kit
K170481 · Hardy Diagnostics
PQZ · Gbs Culture Media, Selective And Differential · 89d
Cleared May 11, 2017
Solana C. difficile Assay
K170491 · Quidel Corporation
OZN · C. Difficile Toxin Gene Amplification Assay · 83d
Cleared May 11, 2017
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
K170413 · Bio-Rad Laboratories
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 90d
Cleared May 02, 2017
BD MAX Extended Enteric Bacterial Panel, BD MAX System
K170308 · Becton, Dickinson and Company
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 90d
Cleared Apr 18, 2017
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
K162297 · Diazyme Laboratories
PTF · Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission · 245d
Cleared Apr 14, 2017
Sofia Influenza A+B FIA on Sofia 2
K162438 · Quidel Corporation
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 226d
Cleared Mar 28, 2017
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
K161816 · bioMerieux, Inc.
MDB · System, Blood Culturing · 270d
Cleared Mar 21, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
K162740 · Beckman Coulter, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 172d
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

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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 JSK Supplement, Culture Media 51