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510(k) K243463

BIOFIRE FILMARRAY Tropical Fever Panel by Biofire Diagnostics, LLC (Biomerieux) — Product Code QMV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2024
Date Received
November 8, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Device Class
Class II
Regulation Number
866.3966
Review Panel
MI
Submission Type

A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.

Other clearances by Biofire Diagnostics, LLC (Biomerieux)

  • K243222 — BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRA (November 6, 2024)

Other clearances for product code QMV

  • K220870 — BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fe (October 20, 2022)
  • DEN200043 — FilmArray Global Fever Panel (November 20, 2020)