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
1901–1925 of 7095
Cleared Nov 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023301 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 40d
Cleared Nov 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML
K023444 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 28d
Cleared Oct 31, 2002
SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
K020689 · Midi, Inc.
NJO · System, Mycolic Acid Analysis, Mycobacterium Tuberculosis · 241d
Cleared Oct 31, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML
K023273 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 30d
Cleared Oct 25, 2002
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
K022356 · Nichols Institute Diagnostics
LYR · Helicobacter Pylori · 98d
Cleared Oct 23, 2002
MICROSCAN SYNERGIES PLUS
K023202 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 28d
Cleared Oct 17, 2002
SAS STREPALERT
K023270 · Sa Scientific, Inc.
GTY · Antigens, All Groups, Streptococcus Spp. · 16d
Cleared Oct 08, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022656 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 60d
Cleared Sep 30, 2002
BIO-RAD PLATELIA TOXO IGM TMB
K013837 · Bio-Rad
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 315d
Cleared Sep 30, 2002
BIO-RAD PLATELIA TOXO IGG TMB
K013839 · Bio-Rad
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 315d
Cleared Sep 27, 2002
EBV EA-D IGG ELISA KIT, MODEL EBG-100
K021793 · Pan Bio Pty. , Ltd.
LSE · Epstein-barr Virus, Other · 119d
Cleared Sep 25, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021997 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 98d
Cleared Sep 25, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022775 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 47d
Cleared Sep 19, 2002
BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
K021646 · Binax, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 122d
Cleared Sep 19, 2002
BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
K021649 · Binax, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 122d
Cleared Sep 17, 2002
IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
K020583 · Ivd Research, Inc.
MHI · Giardia Spp. · 208d
Cleared Sep 17, 2002
GEN-PROBE APTIMA COMBO 2 ASSAY
K022874 · Gen-Probe, Inc.
JTW · System, Transport, Aerobic · 53d
Cleared Sep 13, 2002
RSV OIA
K021172 · Thermo Biostar, Inc.
GOG · Antisera, Cf, Poliovirus 1-3 · 154d
Cleared Sep 13, 2002
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK
K021687 · Binax, Inc.
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 114d
Cleared Aug 22, 2002
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT
K020226 · Hellen Professional Services
JWZ · Kit, Screening, Trichomonas · 212d
Cleared Aug 15, 2002
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
K022045 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 52d
Cleared Aug 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K022172 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 40d
Cleared Aug 01, 2002
HERPESELECT 2 ELISA IGG, MODEL ELO920G
K021486 · Focus Technologies, Inc.
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 90d
Cleared Aug 01, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML
K021954 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 48d
Cleared Jul 29, 2002
HERPESELECT 1 ELISA IGG, MODEL EL0910G
K021429 · Focus Technologies, Inc.
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 87d

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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