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510(k) K091409

LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 by Roche Molecular Systems, Inc. — Product Code NQX

K091409 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727". The FDA issued a decision of Substantially Equivalent on July 6, 2010. 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. Roche Molecular Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2010
Date Received
May 13, 2009
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 Roche Molecular Systems, Inc.

  • K260021 — cobas® BV/CV (July 16, 2026)
  • K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on (July 8, 2026)
  • K253756 — cobas liat CT/NG nucleic acid test (May 15, 2026)
  • K253759 — cobas liat CT/NG/MG nucleic acid test (May 15, 2026)
  • K243753 — cobas liat Bordetella panel nucleic acid test (November 20, 2025)
  • K252481 — cobas CMV (November 3, 2025)
  • K252484 — cobas HCV (November 3, 2025)
  • K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (July 31, 2025)
  • K243863 — Opulus™ Lymphoma Precision (May 30, 2025)
  • K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (April 25, 2025)

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)
  • 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)

FDA data resources