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
1801–1825 of 5928
Cleared Jul 25, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML
K022129 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 24d
Cleared Jul 17, 2002
MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML)
K020413 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 160d
Cleared Jul 13, 2002
BACTEC MGIT 960 PZA KIT
K021582 · Becton, Dickinson & CO
MJA · Susceptibility Test Powders, Antimycobacterial · 60d
Cleared Jun 20, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
K021184 · Dade Microscan, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 66d
Cleared Jun 20, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021627 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 34d
Cleared Jun 17, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
K021181 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 63d
Cleared Jun 11, 2002
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML)
K020410 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 124d
Cleared Jun 11, 2002
MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
K021018 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 74d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
K021078 · Dade Microscan, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 64d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE
K021110 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 62d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
K021111 · Dade Microscan, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 62d
Cleared Jun 06, 2002
MICROSTREP PLUS PANEL, AZITHROMYCIN
K021169 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 56d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME
K021188 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 52d
Cleared Jun 06, 2002
ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
K021445 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 31d
Cleared Jun 03, 2002
MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM
K020938 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 73d
Cleared May 23, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020321 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 128d
Cleared May 17, 2002
MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
K020939 · Dade Microscan, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 56d
Cleared May 16, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
K020398 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 99d
Cleared May 15, 2002
ERTAPENEM 10UG BBL SENSI-DISC
K020842 · Becton, Dickinson & CO
JTN · Susceptibility Test Discs, Antimicrobial · 61d
Cleared May 15, 2002
CEFOTAXIME
K020859 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 58d
Cleared May 09, 2002
GATIFLOXIN
K020762 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 63d
Cleared May 09, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
K020820 · Dade Behring, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 57d
Cleared May 09, 2002
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K021339 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 63d
Cleared May 08, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
K020822 · Dade Behring, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 56d
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
K020627 · Dade Microscan, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 69d

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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