DeviceClearance

Product code NIG— Immunology

AIA-PACK CA 19-9

Classification name
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Device class
Class 2
Regulation
21 CFR 866.6010
Advisory panel
Immunology
Total cleared
12
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NIG under 21 CFR 866.6010, via openFDA

Market context for product code NIG

FDA has cleared 12 devices under product code NIG between 2002 and 2026, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NIG

Adverse events under product code NIG

product code NIG
Malfunction
618
Total
618

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NIG

Data sourced from openFDA. This site is unofficial and independent of the FDA.