# K011143: Tina-Quant D-Dimer Test System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: May 29, 2001 after 46 days
- Product code: GHH (Fibrin Split Products)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030740: Modification to Tina-Quant D-Dimer Test System (2003), 3 descendants of its own
- K062203: Tina-Quant D-Dimer Test System (2007), 1 descendant of its own
- K112120: Diazyme D-Dimer Assay Kit,Calibrator Setand Control Set (2013), 0 descendants of its own
- K070453: Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033, Olympus D-Dimer Control (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K011143
Methodology: https://510kreport.com/methodology