510(k) K023240

ST AIA-PACK CA 19-9 by Tosoh Corp. — Product Code NIG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 23, 2002
Date Received: September 27, 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 Tosoh Corp.

K023239 — AIA-PACK CA 19-9 (December 23, 2002)
K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (July 21, 1992)
K913663 — AIA-PACK T-U (September 30, 1991)
K913298 — AIA-PACK CK-MB (September 27, 1991)
K913493 — AIA-PACK FT4 (September 10, 1991)
K903628 — AIA-PACK IRI (September 7, 1990)
K901965 — MPR-4A - MICRO-PLATE READER (May 10, 1990)
K901674 — AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM (May 2, 1990)
K897001 — TOSOH AIA-PACK T3 (March 9, 1990)
K896982 — AIA-PACK T4 (March 9, 1990)

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)
K023239 — AIA-PACK CA 19-9 (December 23, 2002)
K020566 — FUJIREBIO DIAGNOSTICS CA 19-9 RIA (May 9, 2002)