K220085 is an FDA 510(k) clearance for the KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit. This device is classified as a Tyrosine Phosphatase (ia-2) Autoantibody Assay (Class II - Special Controls, product code OIF).
Submitted by Kronus, Inc. (Star, US). The FDA issued a Cleared decision on August 24, 2023, 590 days after receiving the submission on January 11, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5660. The Device Is Used For The Semi-quantitative Determination Of Autoantibodies Against Tyrosine Phosphatase (ia-2) In Human Serum As An Aid In The Diagnosis Of Type 1 Diabetes Mellitus (autoimmune Mediated Diabetes)..
| 510(k) Number | K220085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2022 |
| Decision Date | August 24, 2023 |
| Days to Decision | 590 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | OIF - Tyrosine Phosphatase (ia-2) Autoantibody Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
| Definition | The Device Is Used For The Semi-quantitative Determination Of Autoantibodies Against Tyrosine Phosphatase (ia-2) In Human Serum As An Aid In The Diagnosis Of Type 1 Diabetes Mellitus (autoimmune Mediated Diabetes). |