# K993276: Simplify D-Dimer, Model DCGK1

- Pathway: 510(k) (Traditional)
- Applicant: Agen Biomedical, Ltd.
- Decided: Dec 14, 1999 after 75 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
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.

## Recalls of this device
- Feb 15, 2007 · Not classified · Z-0594-2007: Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.

## Indications for use
The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-inked D-dimer site) in human whole blood and plasma. The test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombasis and pulmonary embolism.

Source page: https://510kreport.com/device/K993276
Methodology: https://510kreport.com/methodology