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
1876–1900 of 7095
Cleared Mar 21, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML
K030579 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 25d
Cleared Mar 17, 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K024357 · Trek Diagnostic Systems, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 77d
Cleared Mar 06, 2003
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K024353 · Trek Diagnostic Systems, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 66d
Cleared Mar 05, 2003
IVD CRYPTO/GIARDIA DFA
K024113 · Ivd Research, Inc.
MHI · Giardia Spp. · 82d
Cleared Feb 28, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML
K030091 · Bd Diagnostic Systems
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 49d
Cleared Feb 20, 2003
XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
K020595 · Xenotope Diagnostics, Inc.
JWZ · Kit, Screening, Trichomonas · 363d
Cleared Feb 10, 2003
ACON STREP A TWIST TEST DEVICE
K023766 · Acon Laboratories Co.
GTY · Antigens, All Groups, Streptococcus Spp. · 90d
Cleared Feb 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML
K024153 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 55d
Cleared Jan 31, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML
K024152 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 45d
Cleared Jan 29, 2003
SAS RSV TEST
K022845 · Sa Scientific, Inc.
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 155d
Cleared Jan 29, 2003
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
K023677 · Osmetech
LIB · Device, General Purpose, Microbiology, Diagnostic · 89d
Cleared Jan 24, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023568 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 92d
Cleared Jan 17, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K030067 · Ortho-Clinical Diagnostics
MJX · Kit, Serological, Positive Control · 10d
Cleared Jan 14, 2003
RSV OIA
K023779 · Thermo Biostar, Inc.
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 63d
Cleared Jan 08, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN
K023895 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 47d
Cleared Jan 03, 2003
IMMUNOCARD STAT! E. COLI O157 PLUS
K023599 · Meridian Bioscience, Inc.
GMZ · Antigens, All Types, Escherichia Coli · 67d
Cleared Dec 24, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML)
K023634 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 56d
Cleared Dec 23, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML
K023527 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 63d
Cleared Dec 20, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023858 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 30d
Cleared Dec 18, 2002
DFA RESPIRATORY VIRUS SCREENING & ID KIT
K022713 · Diagnostic Hybrids, Inc.
GNW · Antisera, Cf, Influenza Virus A, B, C · 126d
Cleared Dec 16, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML)
K023361 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 70d
Cleared Dec 13, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML)
K023541 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 52d
Cleared Dec 10, 2002
BD DIRECTIGEN EZ RSV KIT
K022133 · Becton, Dickinson & CO
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 162d
Cleared Nov 20, 2002
QUICKLAB RSV
K021789 · Integrated Biotechnology Corp.
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 173d
Cleared Nov 18, 2002
IDI-STREP B ASSAY
K022504 · Infectio Diagnostic, Inc.
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 112d

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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