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
5928 Microbiology devices
1526–1550 of 5928
Cleared Aug 23, 2006
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
K062245 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 21d
Cleared Aug 23, 2006
MICROSCAN MICROSTREP PLUS PANEL
K062276 · Dade Behring, Inc.
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 16d
Cleared Aug 18, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML
K061869 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 46d
Cleared Aug 17, 2006
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY
K060652 · Gen-Probe, Inc.
LSL · Dna-reagents, Neisseria · 157d
Cleared Aug 10, 2006
ENZY-WELL SYPHILIS IGG, MODEL 91106
K050590 · Diesse Diagnostica Senese S.P.A.
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 520d
Cleared Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K053287 · Roche Diagnostics Corp.
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 258d
Cleared Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K053289 · Roche Diagnostics Corp.
LSL · Dna-reagents, Neisseria · 258d
Cleared Aug 10, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML
K061867 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 38d
Cleared Aug 07, 2006
TREP-SURE TREPONEMAL ANTIBODY EIA
K053570 · Phoenix Biotech Corp.
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 228d
Cleared Jul 31, 2006
DIASORIN LIAISON TREPONEMA ASSAY
K061247 · DiaSorin, Inc.
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 89d
Cleared Jul 28, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML
K061673 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 44d
Cleared Jul 25, 2006
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
K053446 · Gen-Probe, Inc.
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 225d
Cleared Jul 25, 2006
XPERT, GENEXPERT DX SYSTEM
K060540 · Cepheid
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 146d
Cleared Jul 21, 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061687 · Dade Behring, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 36d
Cleared Jul 18, 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061536 · Dade Behring, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 46d
Cleared Jul 03, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0.
K061327 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 52d
Cleared Jun 23, 2006
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM
K061301 · Copan Diagnostics, Inc.
JTW · System, Transport, Aerobic · 44d
Cleared Jun 20, 2006
VITEK 2 GRAM POSITIVE VRSA SCREEN
K061347 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 36d
Cleared Jun 12, 2006
OSOM INFLUENZA A&B TEST
K061508 · Genzyme Corp.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 11d
Cleared Jun 07, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML
K061355 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 23d
Cleared Jun 02, 2006
PLATELIA ASPERGILLUS EIA, MODEL 62793
K060641 · Bio-Rad
NOM · Antigen, Galactomannan, Aspergillus Spp. · 84d
Cleared May 25, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE
K060324 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 105d
Cleared May 16, 2006
SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL
K060783 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 55d
Cleared May 12, 2006
PARA-PRO FC50
K053257 · Alpha-Tec Systems, Inc.
LKS · Device, Parasite Concentration · 171d
Cleared May 11, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML
K060558 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 70d

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All categories 5928 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