# K012755: Autodimer Assay Model # 1431

- Pathway: 510(k) (Traditional)
- Applicant: Xtrana, Inc.
- Decided: Mar 15, 2002 after 211 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
AutoDimer Assay is an immunoturbidimetric assay used for the quantitative determination of the fibrin degradation product D-dimer in human plasma, using the Hitachi 911, Hitachi 902, or Thrombolyzer RackRotorTM/Compact XR instruments. AutoDimer Assay utilizes antibody-coated latex particles. The latex particles are coated with a monoclonal antibody reacting with fibrin D-dimer or fragment D of fibrinogen but not with intact fibrinogen, allowing D-dimer determination in human plasma. Laboratory measurements of D-dimer have been shown to be of significance in the assessment of pulmonary embolism, deep, vein thrombosis, and disseminated intravascular coagulation.

Source page: https://510kreport.com/device/K012755
Methodology: https://510kreport.com/methodology