Xpert® Xpress CoV-2 plus (XPRS-COV2-10)— 510(k) K242109

Name: FDA 510(k) clearance K242109
Creator: U.S. Food and Drug Administration
Published: 2025-01-15

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K242109 for Xpert® Xpress CoV-2 plus (XPRS-COV2-10), Substantially Equivalent on 2025-01-15. Applicant: Cepheid®. Device class: 2.

Clearance details

Applicant: Cepheid®
Product code: Code QQX
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2024-07-19
Decision date: 2025-01-15
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QQX

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K243396 — Aptima SARS-CoV-2 Assay2025-02-13
K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems2025-02-11
K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)2024-12-06
K233453 — Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit2024-07-10
K230440 — Xpert® Xpress CoV-2 plus2023-10-13

More clearances from Cepheid®

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K261362 — Xpert Hemorrhagic Fever2026-08-07
K261867 — Xpert Carba-R2026-07-02
K253653 — Xpert Hemorrhagic Fever2026-02-20
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.