# K121610: Cobas C 501 Tina-Quant HBA1CDX Gen.3 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Operations
- Decided: Aug 8, 2013 after 433 days
- Product code: PDJ (Hemoglobin A1c Test System)
- Device class: 2
- Regulation: 21 CFR 862.1373
- Recalls of this device: none
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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
- K180296: Afinion HbA1c Dx (2018), 1 descendant of its own
- K182988: Afinion HbA1c Dx on Afinion 2 (2018), 0 descendants of its own

## Indications for use
This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. The cobas c 501 Tina-quant HbA1cDx Gen.3 assay is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in whole blood on the Roche/Hitachi cobas c 501 clinical chemistry analyzer.

Source page: https://510kreport.com/device/K121610
Methodology: https://510kreport.com/methodology