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
1676–1700 of 5928
Cleared Jun 08, 2004
VITEK 2 ESBL TEST
K040845 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 68d
Cleared Jun 07, 2004
PASCO MIC AND MIC/ID PANELS
K041214 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 28d
Cleared May 28, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST
K033458 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 211d
Cleared May 19, 2004
LIQUICHEK TORCH PLUS IGM CONTROL
K040822 · Bio-Rad Laboratories, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 50d
Cleared May 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML
K040716 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 56d
Cleared Apr 26, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040846 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 25d
Cleared Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE
K033362 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 171d
Cleared Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML
K033907 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 114d
Cleared Apr 07, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040619 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 29d
Cleared Apr 02, 2004
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)
K031601 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 317d
Cleared Apr 02, 2004
GENZYME OSOM TRICHOMONAS RAPID TEST
K033864 · Genzyme Corp.
JWZ · Kit, Screening, Trichomonas · 112d
Cleared Mar 19, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K040099 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 59d
Cleared Mar 11, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE
K040106 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 51d
Cleared Mar 09, 2004
BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY
K033861 · Becton, Dickinson & CO
LQH · Dna-reagents, Legionella · 88d
Cleared Mar 01, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML
K032675 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 185d
Cleared Mar 01, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
K033948 · Dade Behring, Inc.
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 73d
Cleared Feb 27, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE
K040006 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 56d
Cleared Feb 26, 2004
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
K033479 · Remel, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 115d
Cleared Feb 25, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)
K033940 · Dade Behring, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 68d
Cleared Feb 11, 2004
WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
K023889 · Wiener Laboratories Saic
MIU · Enzyme Linked Immunosorbent Assay, T. Cruzi · 447d
Cleared Feb 10, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
K032706 · Dade Behring, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 161d
Cleared Feb 03, 2004
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K033522 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 88d
Cleared Feb 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML
K033784 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 61d
Cleared Feb 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE
K033889 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 49d
Cleared Jan 23, 2004
DUOPATH VEROTOXINS GLISA TEST
K031367 · Emd Chemicals, Inc.
GNA · Antisera, All Types, Escherichia Coli · 268d

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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