# K021877: Mda D-Dimer

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Aug 7, 2002 after 61 days
- Product code: GHH (Fibrin Split Products)
- 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 K000492 (2000). 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)
- K000492: Mda D-Dimer, Organon Teknika Corp. (2000) Summary page 1.

## Indications for use
MDA D-Dimer is a homogeneous latex particle based immunoassay for the quantitative determination of cross-linked fibrin degradation products containing the D-dimer domain in citrated human plasma. MDA D-Dimer is an assay for use in conjunction with a clinical Pre-test Probability Assessment (PTP) model in excluding deep vein thrombosis (DVT) in outpatients suspected of a first episode of DVT. MDA D-Dimer can also be used as an aid in the assessment and evaluation of patients suspected of pulmonary embolism (PE). The assay is designed for use on the MDA automated coagulation analyzers.

Source page: https://510kreport.com/device/K021877
Methodology: https://510kreport.com/methodology