# K030687: K-Assay D-Dimer, K-Assay D-Dimer Calibrator, Models Kai-090; Kaj-091C

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Jun 27, 2003 after 114 days
- Product code: DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Kamiya K-ASSAY D-Dimer Assay is an in vitro diagnostic reagent for the semiquantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay. The K-ASSAY D-Dimer Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY D-Dimer Assay. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K030687
Methodology: https://510kreport.com/methodology