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
5926 Microbiology devices
651–675 of 5926
Cleared Sep 18, 2018
BioSign Flu A+B
K182157 · Princeton BioMeditech Corp.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 40d
Cleared Sep 13, 2018
MTS Penicillin 0.002- 32 µg/mL
K181889 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 62d
Cleared Aug 31, 2018
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
K181464 · DiaSorin, Inc.
LYR · Helicobacter Pylori · 88d
Cleared Aug 30, 2018
Sofia 2 Lyme FIA, Sofia Lyme Control Set
K173496 · Quidel Corporation
LSR · Reagent, Borrelia Serological Reagent · 290d
Cleared Aug 28, 2018
BD MAX CT/GC/TV 20-Day QC Panel
K181683 · Microbiologics, Inc.
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 63d
Cleared Aug 27, 2018
DENV Detect NS1 ELISA
K181473 · InBios International, Inc.
QCU · Dengue Virus Antigen Assay · 84d
Cleared Aug 23, 2018
ADVIA Centaur Herpes-2 IgG
K181334 · Biokit, S.A.
MYF · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 · 94d
Cleared Aug 23, 2018
ADVIA Centaur Herpes-1 IgG
K181333 · Biokit, S.A.
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 94d
Cleared Aug 21, 2018
H. PYLORI CHEK™
K181400 · Techlab, Inc.
LYR · Helicobacter Pylori · 84d
Cleared Aug 21, 2018
H. PYLORI QUIK CHEK
K181379 · Techlab, Inc.
LYR · Helicobacter Pylori · 89d
Cleared Aug 15, 2018
BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
K181711 · Microbiologics, Inc.
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 48d
Cleared Aug 15, 2018
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System
K181289 · Cepheid
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 91d
Cleared Aug 13, 2018
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
K173498 · Diasorin Molecular, LLC
OZZ · Bordetella Pertussis Dna Assay System · 273d
Cleared Aug 08, 2018
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL
K181946 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 19d
Cleared Aug 08, 2018
Alere BinaxNOW Influenza A & B Card 2, Alere Reader
K181853 · Alere Scarborough, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 28d
Cleared Jul 31, 2018
MTS Plazomicin 0.016-256 µg/mL
K181708 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 33d
Cleared Jul 30, 2018
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,
K181736 · Centers For Disease Control and Prevention (Cdc)
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 28d
Cleared Jul 30, 2018
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
K181213 · Siemens Healthcare Diagnostics, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 84d
Cleared Jul 27, 2018
Panther Fusion GBS Assay
K181156 · Diagenode
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 87d
Cleared Jul 24, 2018
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
K180218 · Cepheid
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 180d
Cleared Jul 16, 2018
Atellica IM BRAHMS Procalcitonin (PCT)
K181002 · Siemens Healthcare Diagnostics, Inc.
PMT · Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens · 91d
Cleared Jul 15, 2018
Solana Bordetella Complete Assay
K181029 · Quidel Corporation
OZZ · Bordetella Pertussis Dna Assay System · 88d
Cleared Jul 10, 2018
HardyDisk AST Plazomicin 30ug (PLZ30)
K181700 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 13d
Cleared Jul 06, 2018
CHROMID CARBA agar (CARB)
K181092 · Biomerieux S.A.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 72d
Cleared Jul 06, 2018
Elecsys BRAHMS PCT
K173927 · Roche Diagnostics
PRI · Procalcitonin Assay · 192d

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All categories 5926 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