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
1851–1875 of 7095
Cleared Jul 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML
K031530 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 56d
Not Cleared Jul 08, 2003
WEST NILE VIRUS IGM CAPTURE ELISA
DEN030004 · Panbio Limited
NOP · Elisa, Antibody, West Nile Virus · 5d
Cleared Jun 27, 2003
EBV VCA-P18 IGG ELISA
K030863 · Panbio Limited
LSE · Epstein-barr Virus, Other · 101d
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
Not Cleared Jun 16, 2003
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
DEN030002 · Spectral Diagnostics, Inc.
NGS · Assay, Endotoxin Activity, Chemiluminescent · 63d
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 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML
K031429 · Bd Diagnostic Systems
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 31d
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 06, 2003
KALAZAR DETECT
K023483 · Inbios Intl., Inc.
LOO · Reagent, Leishmanii Serological · 201d
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 17, 2003
GC OIA
K023947 · Thermo Biostar, Inc.
LIR · Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae · 141d
Cleared Apr 14, 2003
URINE MONOVETTE BORIC ACID
K024237 · Sarstedt, Inc.
JSM · Culture Media, Non-propagating Transport · 112d
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
FLU OIA A/B TEST KIT
K023556 · Thermo Biostar, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 155d
Cleared Mar 27, 2003
QUANTA LITE H.PYLORI IGA ELISA
K024334 · Inova Diagnostics, Inc.
LYR · Helicobacter Pylori · 91d
Cleared Mar 26, 2003
BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
K024240 · Bd
JSM · Culture Media, Non-propagating Transport · 93d

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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