510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NIGClass II

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

21 CFR 866.6010 / Immunology
FDA source (opens on fda.gov)

NIG is the FDA product code for System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer, a class II device type, regulated under 21 CFR 866.6010. FDA's definition for this code reads: "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...". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 19 recalls.

Classification record

Product code
NIG
Device name
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
FDA 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.
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
12
Ingested recalls
19

Clearances, product code NIG

By decision year
12 clearances under product code NIG with a decision year between 2002 and 2026, 2002 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code NIG by decision year
YearClearances
20023
20032
20052
20111
20191
20201
20231
20261

Applicants with the most clearances

Product code NIG
Applicants holding the most 510(k) clearances under product code NIG
ApplicantClearances
Fujirebio Diagnostics, Inc.4
Siemens Healthcare Diagnostics Inc.3
Tosoh Corp.2
Medrad, Inc.1
Fujirebio Dianostics, Inc.1
Ortho-Clinical Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order