K221355 is an FDA 510(k) clearance for the VITROS Immuodiagnostic Products CA 125 II Reagent Pack. This device is classified as a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II - Special Controls, product code LTK).
Submitted by Ortho-Clinical Diagnostics (Bridgend, GB). The FDA issued a Cleared decision on December 12, 2022, 216 days after receiving the submission on May 10, 2022.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K221355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2022 |
| Decision Date | December 12, 2022 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LTK — Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |