Xpert® SA Nasal Complete— 510(k) K243070

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K243070 for Xpert® SA Nasal Complete, Substantially Equivalent on 2024-10-25. 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: 2024-09-27
Decision date: 2024-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQX

K243625 — Xpert MRSA/SA SSTI2024-12-18
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
K142721 — cobas MRSA/SA Test2014-12-17

More clearances from Cepheid®

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

Recalls naming K243070

K-number listed on FDA's recall record

Z-0414-2026 — Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid techniqueClass II·Ongoing·Cepheid·20250806

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K243070.

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