FDA Product Code NIG: System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
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.
Leading manufacturers include Fujirebio Diagnostics,Inc., Siemens Healthcare Diagnostics, Inc. and Bayer Healthcare, LLC.
12
Total
12
Cleared
120d
Avg days
2002
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
270d
recently vs 106d historically
FDA 510(k) Cleared System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer Devices (Product Code NIG)
12 devices
Cleared
Aug 10, 2026
Atellica IM CA 19-9 II
Siemens Healthcare Diagnostics, Inc.
Immunology
270d
Cleared
Aug 09, 2023
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
Ortho-Clinical Diagnostics
Immunology
75d
Cleared
May 14, 2020
Lumipulse G CA19-9-N
Fujirebio Diagnostics,Inc.
Immunology
28d
Cleared
Oct 22, 2019
Lumpipulse G CA19-9-N
Fujirebio Dianostics, Inc.
Immunology
90d
Cleared
Apr 06, 2011
DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
Siemens Healthcare Diagnostics, Inc.
Immunology
418d
Cleared
Dec 20, 2005
VITROS CA 19-9
Fujirebio Diagnostics,Inc.
Immunology
68d
Cleared
Oct 25, 2005
ARCHITECT CA 19-9XR ASSAY
Fujirebio Diagnostics,Inc.
Immunology
92d
Cleared
Dec 29, 2003
GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688
Beckman Coulter, Inc.
Immunology
91d
Cleared
Jun 24, 2003
BAYER ADVIA CENTAUR CA 19-9 ASSAY
Bayer Healthcare, LLC
Immunology
53d
Cleared
May 09, 2002
FUJIREBIO DIAGNOSTICS CA 19-9 RIA
Fujirebio Diagnostics,Inc.
Immunology
78d
About Product Code NIG - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code NIG since 2002, with 12 receiving FDA clearance (average review time: 120 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - NIG Product Code
Recent submissions under NIG have taken an average of 270 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.
NIG devices are reviewed by the Immunology panel. Browse all Immunology devices →