NIG · Class II · 21 CFR 866.6010

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 Ortho-Clinical Diagnostics.

11
Total
11
Cleared
106d
Avg days
2002
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer Devices (Product Code NIG)

11 devices
1–11 of 11
Cleared Aug 09, 2023
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
K231525
Ortho-Clinical Diagnostics
Immunology · 75d

About Product Code NIG - Regulatory Context

510(k) Submission Activity

11 total 510(k) submissions under product code NIG since 2002, with 11 receiving FDA clearance (average review time: 106 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

NIG devices are reviewed by the Immunology panel. Browse all Immunology devices →