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The Tracker / October 2026 / K263333

510(k) cleared

Xpert Xpress CoV-2/Flu plus

Cepheid® · Oct 22, 2026 · K263333

FDA cleared the Xpert Xpress CoV-2/Flu plus from Cepheid® on Oct 22, 2026 under K263333, 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 22, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Cepheid® has 2 other decisions in the tracker over the last 12 months: K263120 (Xpert Xpress CoV-2/Flu plus), K261867 (Xpert Carba-R).

Questions & Answers

What did FDA clear under K263333?

K263333 is the FDA 510(k) for Xpert Xpress CoV-2/Flu plus, submitted by Cepheid®. FDA's decision date was Oct 22, 2026, under product code QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents).

Who makes the Xpert Xpress CoV-2/Flu plus?

Cepheid®, based in Sunnyvale, CA, is the applicant of record for K263333.

How long did the K263333 review take?

FDA received the submission on Sep 22, 2026 and issued its decision on Oct 22, 2026, 30 days later.

← All decisions in October 2026

Sources