Xpert Xpress CoV-2/Flu plus— 510(k) K263120

Name: FDA 510(k) clearance K263120
Creator: U.S. Food and Drug Administration
Published: 2026-10-02

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K263120 for Xpert Xpress CoV-2/Flu plus, Substantially Equivalent on 2026-10-02. Applicant: Cepheid®. Device class: 2.

Summary

Xpert Xpress CoV-2/Flu plus from Cepheid 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 full target panel beyond what the name indicates.

Class II, 21 CFR 866.3981. The Microbiology panel reviewed it as a Special 510(k).

Cepheid filed from Sunnyvale, California. Review took 28 days (September 4 to October 2, 2026).

Clearance details

Applicant: Cepheid®
Product code: Product code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2026-09-04
Decision date: 2026-10-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOF

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K261336 — Xpert Respiratory Panel2026-09-25
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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 Cepheid®

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K251721 — Xpert GI Panel2026-01-16
K250995 — Xpert Xpress CoV-2/Flu/RSV plus2025-05-01

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