# K062203: Tina-Quant D-Dimer Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 14, 2007 after 225 days
- Product code: GHH (Fibrin Split Products)
- Device class: 2
- Regulation: 21 CFR 864.7320
- 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: 4 generations back to K862156 (1986). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030740: Modification to Tina-Quant D-Dimer Test System, Roche Diagnostics Corp. (2003) Summary page 2.
- K040882: Vidas D-Dimer Exclusion Assay, Model 30 442, bioMerieux, Inc. (2004). Our reading of the summary gave K040822, FDA’s number for Liquichek Torch Plus Igm Control (Bio-Rad Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Biomerieux Vidas D-Dimer Exclusion Assay”.

## Most influential descendants
- K112120: Diazyme D-Dimer Assay Kit,Calibrator Setand Control Set (2013), 0 descendants of its own

## Recalls of this device
- Oct 3, 2023 · Class II · Z-0352-2024: Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.

## Indications for use
For Roche/Hitachi Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. Inconjunction with a non-high clinical probability assessment, a normal (< 0.5 pg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity. For COBAS Integra: The cassette COBAS Integra Tina-Quant® D-Dimer contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of fibrin degradation products (D-Dimer and X-oligomers) in plasma. Inconjunction with a non-high clinical probability assessment, a normal (< 0.5 pg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.

Source page: https://510kreport.com/device/K062203
Methodology: https://510kreport.com/methodology