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
5934 Microbiology devices
2976–3000 of 5934
Cleared Apr 27, 1993
DISPENS-O-DISC CLARITHROMYCIN 15 MG.
K930911 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 64d
Cleared Apr 27, 1993
DISPENS-O-DISC CEFPODOXIME 10 MCG.
K930946 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 63d
Cleared Apr 23, 1993
NITRATE REAGENTS A, B AND C
K930717 · Hardy Diagnostics
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 71d
Cleared Apr 23, 1993
INDOLE SPOT & INDOLE KOVACS REAGENT
K930718 · Hardy Diagnostics
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 71d
Cleared Apr 23, 1993
VOGUES-PROSKAUER REAGENT A & B
K930720 · Hardy Diagnostics
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 71d
Cleared Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGM EIA
K922580 · Baxter Diagnostics, Inc.
LKQ · Antibody Igm,if, Cytomegalovirus Virus · 316d
Cleared Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGG EIA
K922582 · Baxter Diagnostics, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 316d
Cleared Apr 08, 1993
THREE SPIKE CUP
K922870 · Osteo Technology, Inc.
GRF · Antiserum, Cf, Rubeola · 308d
Cleared Apr 06, 1993
QUIKPAC STREP A TEST
K924007 · Syntron Bioresearch, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 239d
Cleared Apr 05, 1993
ROCHE OXI/FERM II
K923313 · Roche Diagnostic Systems, Inc.
LQM · Gram Negative Identification Panel · 272d
Cleared Apr 05, 1993
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K930055 · Alamar Biosciences Laboratory, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 89d
Cleared Apr 02, 1993
CMV ELISA TEST SYSTEM
K924096 · Zeus Scientific, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 232d
Cleared Mar 26, 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K926545 · Baxter Diagnostics, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 85d
Cleared Mar 24, 1993
CULTURETTE BRAND TOXIN CD TEST
K925329 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LLH · Reagents, Clostridium Difficile Toxin · 154d
Cleared Mar 23, 1993
CODMAN GAAB NEUROENDOSCOPE
K923555 · Codman & Shurtleff, Inc.
GWB · Antisera, Fluorescent, All Types, Streptococcus Pneumoniae · 249d
Cleared Mar 23, 1993
TOXOPLASMA IGM IFA TEST SYSTEM
K924882 · Zeus Scientific, Inc.
GLZ · Antigens, If, Toxoplasma Gondii · 176d
Cleared Mar 23, 1993
VITEK RAPID CALL-GRAM NEGATIV IDENT CARD
K925915 · Biomerieux Vitek, Inc.
LQM · Gram Negative Identification Panel · 120d
Cleared Mar 12, 1993
MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL
K922482 · Baxter Diagnostics, Inc.
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 289d
Cleared Mar 11, 1993
API 20E/UNISCEPT 20E
K924814 · Analytical Products, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 167d
Cleared Mar 11, 1993
CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM
K926017 · Becton Dickinson Microbiology Systems
JSS · Kit, Identification, Enterobacteriaceae · 101d
Cleared Mar 11, 1993
CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM
K926018 · Becton Dickinson Microbiology Systems
JSS · Kit, Identification, Enterobacteriaceae · 101d
Cleared Mar 09, 1993
SENSITITRE SUSCEPTIBILITY PLATES
K923045 · Radiometer America, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 258d
Cleared Mar 04, 1993
BACTEC PEDS PLUS/F
K926304 · Bd Becton Dickinson Vacutainer Systems Preanalytic
MDB · System, Blood Culturing · 79d
Cleared Feb 25, 1993
VIDAS TOXOPLASMA GONDII IGM ASSSAY
K923166 · Biomerieux Vitek, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 241d
Cleared Feb 12, 1993
VIDAS CMV IGG ASSAY
K920661 · Vitek Systems, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 365d

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All categories 5934 JWY Manual Antimicrobial Susceptibility Test Systems 408 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 OCC Respiratory Virus Panel Nucleic Acid Assay System 75 LYR Helicobacter Pylori 75