K231525 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack. This device is classified as a System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer (Class II - Special Controls, product code NIG).
Submitted by Ortho-Clinical Diagnostics (Bridgend, GB). The FDA issued a Cleared decision on August 9, 2023, 75 days after receiving the submission on May 26, 2023.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010. 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..
| 510(k) Number | K231525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2023 |
| Decision Date | August 09, 2023 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | NIG — System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |
| 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. |