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
5939 Microbiology devices
3551–3575 of 5939
Cleared Nov 30, 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
K884517 · Kallestad Diag, A Div. of Erbamont, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 34d
Cleared Nov 22, 1988
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION
K884191 · Baxter Diagnostics, Inc.
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 47d
Cleared Nov 22, 1988
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
K884192 · Baxter Diagnostics, Inc.
LKT · Respiratory Syncytial Virus, Antigen, Antibody, Ifa · 47d
Cleared Nov 22, 1988
PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT
K884193 · Baxter Diagnostics, Inc.
GQS · Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 · 47d
Cleared Nov 22, 1988
PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT
K884194 · Baxter Diagnostics, Inc.
GQS · Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 · 47d
Cleared Nov 22, 1988
MODIFICATION MIC/API UNISCEPT(R)
K884509 · Analytical Products, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 26d
Cleared Nov 22, 1988
MODIFICATION MICRO-MIC
K884510 · Analytical Products, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 26d
Cleared Nov 10, 1988
KODAK SURECELL CHLAMYDIA TEST KIT
K882923 · Eastman Kodak Company
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 120d
Cleared Nov 03, 1988
NOVAPATH SPECIMEN COLLECTION KIT
K884342 · Bio-Rad
LIO · Device, Specimen Collection · 20d
Cleared Nov 01, 1988
PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM
K884357 · Precision Dynamics Corp.
KOT · Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium · 15d
Cleared Oct 31, 1988
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
K882629 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 126d
Cleared Oct 31, 1988
FIAGEN RUBELLA IGG
K883182 · Cyberfluor, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 95d
Cleared Oct 27, 1988
SCEPTORPETTE SYSTEM
K883907 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 42d
Cleared Oct 25, 1988
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
K883083 · Medical Diagnostic Technologies, Inc.
GSA · Antisera, All Mycoplasma Spp. · 96d
Cleared Oct 25, 1988
CDT CYTOTOXI TEST
K883560 · Advanced Clinical Diagnostics
LLH · Reagents, Clostridium Difficile Toxin · 67d
Cleared Oct 25, 1988
RUBELLA IGM MICROASSAY
K883778 · Diamedix Corp.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 49d
Cleared Oct 25, 1988
LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)
K884208 · Oxoid U.S.A., Inc.
KZI · Culture Media, Enriched · 19d
Cleared Oct 12, 1988
SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL
K883798 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JWY · Manual Antimicrobial Susceptibility Test Systems · 35d
Cleared Oct 12, 1988
SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL
K883800 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JWY · Manual Antimicrobial Susceptibility Test Systems · 35d
Cleared Oct 12, 1988
X-ACT UREA/TDA
K883995 · Pro-Lab, Inc.
JSE · Culture Media, Multiple Biochemical Test · 22d
Cleared Oct 12, 1988
X-ACT LDC/IND
K883996 · Pro-Lab, Inc.
JSE · Culture Media, Multiple Biochemical Test · 22d
Cleared Oct 12, 1988
QUIDEL GROUP A STREP TEST
K883999 · Quidel Corp.
GTZ · Antisera, All Groups, Streptococcus Spp. · 23d
Cleared Oct 06, 1988
AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200
K882475 · Amersham Corp.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 113d
Cleared Oct 06, 1988
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI
K883352 · Whittaker Bioproducts, Inc.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 58d
Cleared Oct 06, 1988
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST
K883936 · Ortho Diagnostic Systems, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 17d

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All categories 5939 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 99 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