# K080069: Dimertest

- Pathway: 510(k) (Traditional)
- Applicant: American Diagnostica, Inc.
- Decided: Feb 13, 2008 after 34 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
Longest line of descent: 1 generation back to K882944 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882944: Dimertest (R) Latex, Agen Biomedical, Ltd. (1988) Summary page 1.

## Indications for use
The DIMERTEST® Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma.

Source page: https://510kreport.com/device/K080069
Methodology: https://510kreport.com/methodology