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
1976–2000 of 7095
Cleared Mar 27, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020322 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 71d
Cleared Mar 26, 2002
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014259 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 90d
Cleared Mar 25, 2002
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
K020870 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 87d
Cleared Mar 22, 2002
DRIED GRAM NEGATIVE MIC/COMBO PANELS
K020037 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 77d
Cleared Mar 20, 2002
PASCO MIC AND MIC/ID PANELS
K020331 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 48d
Cleared Mar 14, 2002
MICROSCAN SYNERGIES PLUS
K020142 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 57d
Cleared Mar 14, 2002
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
K020160 · Dade Behring, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 56d
Cleared Mar 14, 2002
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN
K020162 · Dade Behring, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 56d
Cleared Mar 14, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML)
K020248 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 49d
Cleared Mar 06, 2002
MICROSCAN SYNERGIES PLUS
K020511 · Dade Microscan, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 19d
Cleared Feb 28, 2002
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
K013819 · Sierra Diagnostic, LLC
JTW · System, Transport, Aerobic · 104d
Cleared Feb 19, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014258 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 55d
Cleared Feb 19, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML)
K020328 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 19d
Cleared Feb 08, 2002
PYLORITEK VP TEST KIT 5140VP
K014038 · Serim Research Corp.
LYR · Helicobacter Pylori · 63d
Cleared Feb 06, 2002
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)
K020168 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 20d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)
K020173 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 20d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML)
K020182 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 19d
Cleared Feb 06, 2002
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML)
K020185 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 19d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML)
K020209 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 15d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)
K020246 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 13d
Cleared Feb 06, 2002
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
K020249 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 13d
Cleared Jan 24, 2002
CAPTIAM SYPHILIS-G ASSAY
K014233 · Trinity Biotech, Plc
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 29d
Cleared Jan 17, 2002
BREATHTEK - UBIT UBT FOR H. PYLORI
K014225 · Meretek Diagnostics, Inc.
MSQ · Test, Urea (breath Or Blood) · 22d
Cleared Jan 10, 2002
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6
K012075 · Diagnostic Products Corp.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 192d
Cleared Jan 10, 2002
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
K012077 · Diagnostic Products Corp.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 192d

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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