K160571 is an FDA 510(k) clearance for the cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay. This device is classified as a Hemoglobin A1c Test System (Class II - Special Controls, product code PDJ).
Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on December 19, 2016, 294 days after receiving the submission on February 29, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1373. Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes..
| 510(k) Number | K160571 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 2016 |
| Decision Date | December 19, 2016 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PDJ — Hemoglobin A1c Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1373 |
| Definition | Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes. |