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The Tracker / September 2026 / K263054

510(k) cleared

BIOFIRE Respiratory Panel 2.1 (RP2.1)

Biofire Diagnostics · Sep 22, 2026 · K263054

FDA cleared the BIOFIRE Respiratory Panel 2.1 (RP2.1) from Biofire Diagnostics on Sep 22, 2026 under K263054, a special 510(k). The device falls under product code QOF, Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, regulated at 21 CFR 866.3981 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Sep 1, 2026. The decision came 21 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Biofire Diagnostics in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K263054?

K263054 is the FDA 510(k) for BIOFIRE Respiratory Panel 2.1 (RP2.1), submitted by Biofire Diagnostics. FDA's decision date was Sep 22, 2026, under product code QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents).

Who makes the BIOFIRE Respiratory Panel 2.1 (RP2.1)?

Biofire Diagnostics, based in Salt Lake City, UT, is the applicant of record for K263054.

How long did the K263054 review take?

FDA received the submission on Sep 1, 2026 and issued its decision on Sep 22, 2026, 21 days later.

← All decisions in September 2026