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The Tracker / September 2026 / K261336

510(k) cleared

Xpert Respiratory Panel

Cepheid · Sep 25, 2026 · K261336

FDA cleared the Xpert Respiratory Panel from Cepheid on Sep 25, 2026 under K261336, a traditional 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 Apr 23, 2026. The decision came 155 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Cepheid has 3 other decisions in the tracker over the last 12 months: K261362 (Xpert Hemorrhagic Fever), K253653 (Xpert Hemorrhagic Fever), K251721 (Xpert GI Panel).

Questions & Answers

What did FDA clear under K261336?

K261336 is the FDA 510(k) for Xpert Respiratory Panel, submitted by Cepheid. FDA's decision date was Sep 25, 2026, under product code QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents).

Who makes the Xpert Respiratory Panel?

Cepheid, based in Sunnyvale, CA, is the applicant of record for K261336.

How long did the K261336 review take?

FDA received the submission on Apr 23, 2026 and issued its decision on Sep 25, 2026, 155 days later.

← All decisions in September 2026

Sources