# DEN130002: Tina-Quant HBA1C Gen. 2 Test System

- Pathway: De Novo (Post-NSE)
- Applicant: Roche Diagnostics
- Decided: May 23, 2013 after 59 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
No predicates in its family tree.
23 later devices descend from it; 7 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K142448: VARIANT II TURBO HbA1c Kit - 2.0 (2015), 6 descendants of its own
- K151321: D-100 HbA1c, D-100 HbA1c Calibrator Pack (2015), 4 descendants of its own
- K130255: Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls (2014), 4 descendants of its own
- K131580: Automated Gylcohemoglobin Analyzer HLC-723G8 (2014), 3 descendants of its own
- K121610: Cobas C 501 Tina-Quant HBA1CDX Gen.3 Assay (2013), 2 descendants of its own

Source page: https://510kreport.com/device/DEN130002
Methodology: https://510kreport.com/methodology