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510(k) K020566

FUJIREBIO DIAGNOSTICS CA 19-9 RIA by Fujirebio Diagnostics,Inc. — Product Code NIG

K020566 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "FUJIREBIO DIAGNOSTICS CA 19-9 RIA". The FDA issued a decision of Substantially Equivalent on May 9, 2002. 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. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2002
Date Received
February 20, 2002
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 Fujirebio Diagnostics,Inc.

  • K250925 — ADVIA Centaur Cytokeratin Fragment 21-1 (December 16, 2025)
  • K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (May 16, 2025)
  • DEN200072 — Lumipulse G ß-Amyloid Ratio (1-42/1-40) (May 4, 2022)
  • K192524 — Lumipulse G CA15-3 (September 4, 2020)
  • K192380 — ST AIA-PACK BNP (August 24, 2020)
  • K200997 — Lumipulse G CA19-9-N (May 14, 2020)
  • K190702 — Lumipulse G whole PTH (August 30, 2019)
  • K172713 — Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S P (December 10, 2017)
  • K171103 — Lumipulse G TSH-III Immunoreaction Cartridges (July 28, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)

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)
  • K031393 — BAYER ADVIA CENTAUR CA 19-9 ASSAY (June 24, 2003)
  • K023240 — ST AIA-PACK CA 19-9 (December 23, 2002)
  • K023239 — AIA-PACK CA 19-9 (December 23, 2002)

FDA data resources