FDA product code NIG: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
NIG is the FDA product code for system, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 12 510(k) submissions under NIG, 2 in the last five years, from 7 different applicants. The average 510(k) review took 120 days (median 87); 270 days on average over the last three years. FDA has posted 19 recalls for NIG devices, 5 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NIG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 90 |
| 2020 | 1 | 28 |
| 2023 | 1 | 75 |
| 2026 | 1 | 270 |
Compare with all 510(k) review times · Search every NIG clearance
Top NIG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fujirebio Diagnostics,Inc. | 4 | 2020-05-14 |
| Siemens Healthcare Diagnostics, Inc. | 2 | 2026-08-10 |
| Tosoh Corp. | 2 | 2002-12-23 |
| Ortho Clinical Diagnostics | 1 | 2023-08-09 |
| Fujirebio Dianostics, Inc. | 1 | 2019-10-22 |
2 more applicants have NIG clearances. See the full list in Caduvo.
Most recent NIG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253528 | Siemens Healthcare Diagnostics, Inc. | Atellica IM CA 19-9 II | 2026-08-10 | 270 |
| K231525 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | 2023-08-09 | 75 |
| K200997 | Fujirebio Diagnostics,Inc. | Lumipulse G CA19-9-N | 2020-05-14 | 28 |
| K191973 | Fujirebio Dianostics, Inc. | Lumpipulse G CA19-9-N | 2019-10-22 | 90 |
| K100375 | Siemens Healthcare Diagnostics, Inc. | DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 | 2011-04-06 | 418 |
Recalls for NIG devices
19 product recalls in 14 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2024-07-26.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2024 | 5 |
Frequently asked questions
What is FDA product code NIG?
NIG is the FDA product code for system, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is NIG?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code NIG?
Across 12 cleared submissions the average was 120 days from receipt to decision (median 87).
Which companies have the most NIG clearances?
Fujirebio Diagnostics,Inc. (4); Siemens Healthcare Diagnostics, Inc. (2); Tosoh Corp. (2); Ortho Clinical Diagnostics (1); Fujirebio Dianostics, Inc. (1).
Have NIG devices been recalled?
Yes: 19 product recalls across 14 recall events; the most recent began 2024-07-26.
Next steps
- Run an FDA pathway report with predicate devices for product code NIG
- Run a recall and safety report across every NIG manufacturer
- Watch product code NIG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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