# K070453: Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033, Olympus D-Dimer Control

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Life & Material Science Europa GmbH (Irish
- Decided: Jun 11, 2007 after 115 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: 2 generations back to K002706 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 1.
- K002706: Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche Diagnostics Tina-Quant D-Dimer on Hitachi, Roche Diagnostics Corp. (2001) Summary page 1.

## Indications for use
System reagent for the quantitative determination of D-Dimer in human plasma on OLYMPUS analyzers. Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation.

Source page: https://510kreport.com/device/K070453
Methodology: https://510kreport.com/methodology