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510(k) K031393

BAYER ADVIA CENTAUR CA 19-9 ASSAY by Bayer Healthcare, LLC — Product Code NIG

K031393 is an FDA 510(k) premarket notification submitted by Bayer Healthcare, LLC for the device "BAYER ADVIA CENTAUR CA 19-9 ASSAY". The FDA issued a decision of Substantially Equivalent on June 24, 2003. The device falls under product code NIG (System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer), a Class II device regulated under 21 CFR 866.6010. Bayer Healthcare, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2003
Date Received
May 2, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

An in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen in human serum or plasma. The test is intended as an aid in the management of patients with confirmed pancreatic cancer and serial monitoring of their response to therapy and disease progression. The test should only be used in patients with serum and plasma CA 19-9 values above the cut-off at the time of diagnosis and in conjunction with other clinical methods.

Other clearances by Bayer Healthcare, LLC

  • K171802 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) (March 7, 2018)
  • K152852 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (December 22, 2015)
  • K150942 — Contour Next USB Blood Glucose Monitoring System (November 25, 2015)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K130265 — CONTOUR NEXT EZ BLOOD GLUCOSE METER (June 23, 2014)
  • K122370 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR (September 26, 2013)
  • K121190 — CONTOUR NEXT BLOOD GLUCOSE METER (July 26, 2012)
  • K121087 — CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM (June 28, 2012)
  • K110894 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER (March 28, 2012)
  • K110587 — CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CON (March 28, 2012)

Other clearances for product code NIG

  • K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (August 9, 2023)
  • K200997 — Lumipulse G CA19-9-N (May 14, 2020)
  • K191973 — Lumpipulse G CA19-9-N (October 22, 2019)
  • K100375 — DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRA (April 6, 2011)
  • K052889 — VITROS CA 19-9 (December 20, 2005)
  • K052000 — ARCHITECT CA 19-9XR ASSAY (October 25, 2005)
  • K033038 — GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 3 (December 29, 2003)
  • K023240 — ST AIA-PACK CA 19-9 (December 23, 2002)
  • K023239 — AIA-PACK CA 19-9 (December 23, 2002)
  • K020566 — FUJIREBIO DIAGNOSTICS CA 19-9 RIA (May 9, 2002)

FDA data resources