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510(k) K191742

ARIES MRSA Assay by Luminex Corporation — Product Code NQX

K191742 is an FDA 510(k) premarket notification submitted by Luminex Corporation for the device "ARIES MRSA Assay". The FDA issued a decision of Substantially Equivalent on September 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. Luminex Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2019
Date Received
July 1, 2019
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 Luminex Corporation

  • K253722 — LIAISON PLEX Gastrointestinal Flex Assay (May 19, 2026)
  • K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay (June 6, 2025)
  • K243013 — LIAISON PLEX Gram-Negative Blood Culture Assay (April 18, 2025)
  • K240627 — LIAISON PLEX Yeast Blood Culture Assay (June 4, 2024)
  • K233410 — LIAISON PLEX Respiratory Flex Assay (March 1, 2024)
  • K172402 — ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit (October 30, 2017)
  • K171441 — ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Ki (July 21, 2017)
  • K163626 — ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (May 2, 2017)
  • K162772 — ARIES GBS Assay (December 23, 2016)
  • K161220 — ARIES® Flu A/B & RSV Assay (August 2, 2016)

Other clearances for product code NQX

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

FDA data resources