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510(k) K063451

GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 by Gen-Probe, Inc. — Product Code MKZ

K063451 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199". The FDA issued a decision of Substantially Equivalent on January 22, 2007. The device falls under product code MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia), a Class I device regulated under 21 CFR 866.3120. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2007
Date Received
November 15, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna Probe, Nucleic Acid Amplification, Chlamydia
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

Other clearances by Gen-Probe, Inc.

  • K122062 — APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER (January 9, 2013)
  • K111409 — APTIMA COMBO 2 ASSAY (May 3, 2012)
  • K063664 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 (January 25, 2007)
  • K062440 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 (November 7, 2006)
  • K061413 — APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (October 13, 2006)
  • K061509 — TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 (October 4, 2006)
  • K060652 — TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY (August 17, 2006)
  • K053446 — GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 (July 25, 2006)
  • K043224 — GEN-PROBE APTIMA COMBO 2 ASSAY (August 9, 2005)
  • K043144 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE (March 14, 2005)

Other clearances for product code MKZ

  • K230451 — Aptima® Chlamydia trachomatis Assay (November 16, 2023)
  • K140446 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (May 20, 2014)
  • K110923 — COBAS 4800 CT / NG TEST (January 24, 2012)
  • K091724 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (November 13, 2009)
  • K090824 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (June 2, 2009)
  • K081824 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (December 11, 2008)
  • K080739 — ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT (July 10, 2008)
  • K070174 — AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCE (April 16, 2007)
  • K061413 — APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (October 13, 2006)
  • K053287 — COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (August 10, 2006)

FDA data resources