BIOFIRE Respiratory Panel 2.1 (RP2.1)— 510(k) K263054

Name: FDA 510(k) clearance K263054
Creator: U.S. Food and Drug Administration
Published: 2026-09-22

Substantially Equivalent

Biofire Diagnostics

FDA 510(k) clearance K263054 for BIOFIRE Respiratory Panel 2.1 (RP2.1), Substantially Equivalent on 2026-09-22. Applicant: Biofire Diagnostics. Device class: 2.

Summary

The BIOFIRE Respiratory Panel 2.1 (RP2.1) is filed under QOF, multi-target respiratory specimen nucleic acid tests that include SARS-CoV-2 and other microbial agents. The record doesn't list the targets.

Class II, 21 CFR 866.3981, Microbiology panel. Biofire Diagnostics filed it as a Special 510(k).

Biofire filed from Salt Lake City, Utah. Review took 21 days (September 1 to September 22, 2026).

Clearance details

Applicant: Biofire Diagnostics
Product code: Product code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2026-09-01
Decision date: 2026-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOF

view all

K263120 — Xpert Xpress CoV-2/Flu plus2026-10-02
K261336 — Xpert Respiratory Panel2026-09-25
K261837 — FINDER Flu A&B/SARS-CoV-2 Test2026-09-11
K252932 — Fast PCR Mini Respiratory Panel2026-06-12
K252269 — FINDER Flu A&B/SARS-CoV-2 Test2026-03-30

More clearances from Biofire Diagnostics

view all

K213954 — BIOFIRE SPOTFIRE Respiratory (R) Panel2023-02-03
K140407 — FILMARRAY GASTROINTESTINAL (GI) PANEL2014-05-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.