XPERT MRSA— 510(k) K070462

Substantially Equivalent

Cepheid

FDA 510(k) clearance K070462 for XPERT MRSA, Substantially Equivalent on 2007-04-17. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code NQX
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2007-02-16
Decision date: 2007-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQX

K243625 — Xpert MRSA/SA SSTI2024-12-18
K243070 — Xpert® SA Nasal Complete2024-10-25
K191742 — ARIES MRSA Assay2019-09-25
K190771 — Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System2019-04-25
K162444 — Xpert MRSA NxG2016-11-23

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K261362 — Xpert Hemorrhagic Fever2026-08-07
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K253653 — Xpert Hemorrhagic Fever2026-02-20
K251721 — Xpert GI Panel2026-01-16
K250995 — Xpert Xpress CoV-2/Flu/RSV plus2025-05-01

Recalls naming K070462

K-number listed on FDA's recall record

Z-2548-2016 — Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonizationClass II·Terminated·Cepheid·20160718

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070462.

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