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510(k) K190771

Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System by Cepheid — Product Code NQX

K190771 is an FDA 510(k) premarket notification submitted by Cepheid for the device "Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System". The FDA issued a decision of Substantially Equivalent on April 25, 2019. The device falls under product code NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen), a Class II device regulated under 21 CFR 866.1640. Cepheid has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2019
Date Received
March 26, 2019
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

  • K253653 — Xpert Hemorrhagic Fever (February 20, 2026)
  • K251721 — Xpert GI Panel (January 16, 2026)
  • K250218 — Xpert® FII & FV (February 21, 2025)
  • K242071 — Xpert Xpress CoV-2/Flu/RSV plus (January 10, 2025)
  • DEN240016 — Xpert HCV; GeneXpert Xpress System (June 27, 2024)
  • K231381 — Xpert Xpress MVP; GeneXpert Xpress System (October 19, 2023)
  • K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (September 27, 2023)
  • K221160 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (June 7, 2022)
  • K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (May 9, 2022)
  • K212213 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (February 9, 2022)

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)
  • 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)

FDA data resources