510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160459Substantially Equivalent

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

BioFire Diagnostics, LLC, Salt Lake City UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160459 is the FDA 510(k) clearance record for FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch, a class II device, cleared for Biofire Diagnostics, LLC on under FDA product code PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System). FDA's definition for product code PCH reads: "A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool...". FDA records list 35 510(k) clearances for Biofire Diagnostics, LLC, from to . As of , FDA records show 6 recalls naming K160459.

Clearance record

Decision date
Received
(42 days to decision)
Product code
PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Regulation
21 CFR 866.3990
Device class
Class II
Review panel
Microbiology
Applicant
Biofire Diagnostics, LLC 390 Wakara Way, Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PCH

Trailing 12 months
3 clearances under product code PCH in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PCH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260