Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System— 510(k) K221160

Name: FDA 510(k) clearance K221160
Creator: U.S. Food and Drug Administration
Published: 2022-06-07

Substantially Equivalent

Cepheid

FDA 510(k) clearance K221160 for Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System, Substantially Equivalent on 2022-06-07. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code PQA
Device class: Class 2
Regulation: 21 CFR 866.3975
Advisory panel: Microbiology
Date received: 2022-04-21
Decision date: 2022-06-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PQA

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K260021 — cobas® BV/CV2026-07-16
K243725 — BD Vaginal Panel2024-12-19
K243345 — Aptima BV Assay; Aptima CV/TV Assay2024-11-25
K231381 — Xpert Xpress MVP; GeneXpert Xpress System2023-10-19
K223653 — BD Vaginal Panel2023-03-06

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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.