# K041438: Advanced D-Dimer Assay

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 11, 2004 after 71 days
- Product code: DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K862156 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992957: Advanced D-Dimer, Dade Behring, Inc. (2000) Summary page 1.

## Recalls of this device
- Jul 29, 2005 · Not classified · Z-0172-06: Reports of false negative results on Sysmex Coagulation System.
- Dec 3, 2004 · Not classified · Z-0538-05: decrease in product stability after reconstitution and reduced stability on board certain instrument systems

## Indications for use
Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in human plasma for use with Dade Behring Coagulation Analyzes and Sysmex® Coagulation Systems. The Advanced D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].

Source page: https://510kreport.com/device/K041438
Methodology: https://510kreport.com/methodology