Xpert Respiratory Panel— 510(k) K261336

Name: FDA 510(k) clearance K261336
Creator: U.S. Food and Drug Administration
Published: 2026-09-25

Substantially Equivalent

Cepheid

FDA 510(k) clearance K261336 for Xpert Respiratory Panel, Substantially Equivalent on 2026-09-25. Applicant: Cepheid. Device class: 2.

Summary

Cepheid's Xpert Respiratory Panel 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 specific targets on the panel.

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

Cepheid filed from Sunnyvale, California. Review took 155 days (April 23 to September 25, 2026).

Clearance details

Applicant: Cepheid
Product code: Product code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2026-04-23
Decision date: 2026-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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K250995 — Xpert Xpress CoV-2/Flu/RSV plus2025-05-01

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