# K160571: cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Operations (Rdo)
- Decided: Dec 19, 2016 after 294 days
- Product code: PDJ (Hemoglobin A1c Test System)
- Device class: 2
- Regulation: 21 CFR 862.1373
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130002 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130002: Tina-Quant HBA1C Gen. 2 Test System, Roche Diagnostics (2013). Our reading of the summary gave K121291, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130002, Tina-Quant HBA1C Gen. 2 Test System (Roche Diagnostics), granted May 23, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K173909: Dimension Hemoglobin A1c Assay (2018), 0 descendants of its own

## Recalls of this device
- Jul 18, 2019 · Class II · Z-2478-2019: Quality issue with high pressure solenoid valves

## Indications for use
The cobas c 513 clinical chemistry analyzer is a fully automated, standalone clinical chemistry analyzer intended for the in-vitro quantitative determination of analytes in body fluids. The Tina-quant Hemoglobin A1cDx Gen.3 assay is intended for use as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. It is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood on the Roche/Hitachi cobas c 513 clinical chemistry analyzer. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K160571
Methodology: https://510kreport.com/methodology