# K112120: Diazyme D-Dimer Assay Kit,Calibrator Setand Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Jan 24, 2013 after 549 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: 5 generations back to K862156 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062203: Tina-Quant D-Dimer Test System, Roche Diagnostics Corp. (2007) Summary page 2.

## Indications for use
The D-Dimer Assay is for the quantitative determination of fibrinogen/fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only. The Diayzme D-Dimer Assay Calibrator Set is intended for use in the calibration of the D-Dimer assay only. For in vitro diagnostic use only. The Diazyme D-Dimer Assay Control Set is intended for use as quality controls for the Diazyme D-Dimer assay only. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K112120
Methodology: https://510kreport.com/methodology