510(k) K142721

cobas MRSA/SA Test by Roche Molecular Systems, Inc. — Product Code NQX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 17, 2014
Date Received: September 23, 2014
Clearance Type: Traditional
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.

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Other clearances for product code NQX

K243625 — Xpert MRSA/SA SSTI (December 18, 2024)
K243070 — Xpert® SA Nasal Complete (October 25, 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)
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)