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NIG — System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer Class II

FDA Device Classification

Classification Details

Product Code
NIG
Device Class
Class II
Regulation Number
866.6010
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231525ortho clinical diagnosticsVITROS Immunodiagnostic Products CA 19-9TM Reagent PackAugust 9, 2023
K200997fujirebio diagnosticsLumipulse G CA19-9-NMay 14, 2020
K191973fujirebio dianosticsLumpipulse G CA19-9-NOctober 22, 2019
K100375siemens healthcare diagnosticsDIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRAApril 6, 2011
K052889fujirebio diagnosticsVITROS CA 19-9December 20, 2005
K052000fujirebio diagnosticsARCHITECT CA 19-9XR ASSAYOctober 25, 2005
K033038beckman coulterGI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 3December 29, 2003
K031393bayer healthcareBAYER ADVIA CENTAUR CA 19-9 ASSAYJune 24, 2003
K023240tosohST AIA-PACK CA 19-9December 23, 2002
K023239tosohAIA-PACK CA 19-9December 23, 2002
K020566fujirebio diagnosticsFUJIREBIO DIAGNOSTICS CA 19-9 RIAMay 9, 2002