# K030740: Modification to Tina-Quant D-Dimer Test System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 1, 2003 after 22 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
Longest line of descent: 1 generation back to K002706 (2001). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002706: Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche Diagnostics Tina-Quant D-Dimer on Hitachi, Roche Diagnostics Corp. (2001) Summary page 2.
- K011143: Tina-Quant D-Dimer Test System, Roche Diagnostics Corp. (2001)

## Most influential descendants
- 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

## Indications for use
Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers in plasma.

Source page: https://510kreport.com/device/K030740
Methodology: https://510kreport.com/methodology