K171731 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 January 19, 2018, 221 days after receiving the submission on June 12, 2017.
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 | K171731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2017 |
| Decision Date | January 19, 2018 |
| Days to Decision | 221 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). |