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510(k) K133605

BD MAX MRSA XT, BD MAX INSTRUMENT by Geneohm Sciences Canada, Inc. — Product Code NQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2013
Date Received
November 25, 2013
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.

Other clearances by Geneohm Sciences Canada, Inc.

  • K061686 — IDI-VANR ASSAY (August 30, 2006)

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  • 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)