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
1751–1775 of 5928
Cleared Jun 24, 2003
BD VIPER INSTRUMENT
K023955 · Becton, Dickinson & CO
JQW · Station, Pipetting And Diluting, For Clinical Use · 209d
Cleared Jun 20, 2003
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
K031606 · Beckman Coulter, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 29d
Cleared Jun 13, 2003
PASCO MIC AND MIC/ID PANELS
K031205 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 58d
Cleared Jun 12, 2003
PASCO MIC AND MIC/ID PANELS (ERTAPENEM)
K031103 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 66d
Cleared Jun 10, 2003
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
K024360 · Alfa Scientific Designs, Inc.
LYR · Helicobacter Pylori · 162d
Cleared Jun 02, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE
K031306 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 39d
Cleared Jun 02, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
K031506 · Beckman Coulter, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 19d
Cleared May 16, 2003
PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
K023857 · Bio-Rad
NOM · Antigen, Galactomannan, Aspergillus Spp. · 177d
Cleared May 16, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML
K030986 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 49d
Cleared May 01, 2003
PASCO MIC AND MIC/ID PANELS
K030933 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 37d
Cleared Apr 24, 2003
C. DIFFICILE TOX A/B II
K030404 · Techlab, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 77d
Cleared Apr 14, 2003
PASCO MIC AND MIC/ID PANELS
K030620 · Pasco Laboratories, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 46d
Cleared Apr 02, 2003
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
K024350 · ACON Laboratories, Inc.
LYR · Helicobacter Pylori · 93d
Cleared Apr 01, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE
K030677 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 28d
Cleared Mar 27, 2003
QUANTA LITE H.PYLORI IGA ELISA
K024334 · Inova Diagnostics, Inc.
LYR · Helicobacter Pylori · 91d
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 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 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 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

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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