510(k) K243070

Xpert® SA Nasal Complete by Cepheid® — Product Code NQX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 25, 2024
Date Received: September 27, 2024
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Device Class: Class II
Regulation Number: 866.1640
Review Panel: MI
Submission Type

A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.

Other clearances by Cepheid®

K250995 — Xpert Xpress CoV-2/Flu/RSV plus (May 1, 2025)
K250996 — Xpert Xpress CoV-2/Flu/RSV plus (May 1, 2025)
K243730 — Xpert C. difficile/Epi (February 28, 2025)
K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (January 15, 2025)
K243625 — Xpert MRSA/SA SSTI (December 18, 2024)
K243405 — Xpert vanA (November 21, 2024)
K230440 — Xpert® Xpress CoV-2 plus (October 13, 2023)
K231481 — Xpert Xpress CoV-2/Flu/RSV plus (August 17, 2023)
K223046 — Xpert® FII & FV (February 15, 2023)

Other clearances for product code NQX

K243625 — Xpert MRSA/SA SSTI (December 18, 2024)
K191742 — ARIES MRSA Assay (September 25, 2019)
K190771 — Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, (April 25, 2019)
K162444 — Xpert MRSA NxG (November 23, 2016)
K142721 — cobas MRSA/SA Test (December 17, 2014)
K133605 — BD MAX MRSA XT, BD MAX INSTRUMENT (December 20, 2013)
K132822 — BD MAX STAPHSR ASSAY, INSTRUMENT (November 26, 2013)
K132468 — MRSA/SA ELITE MGB, ELITE MGB SOFTWARE (October 17, 2013)
K130894 — XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX- (June 20, 2013)
K120138 — BD MAX MRSA ASSAY, BD MAX INSTRUMENT (July 5, 2012)