# K042890: Triage D-Dimer Test, Model 98100

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Nov 29, 2004 after 41 days
- Product code: GHH (Fibrin Split Products)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K862156 (1986). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040437: Triage Profiler S.O.B. Panel, Biosite Incorporated (2004) Summary page 1.

## Recalls of this device
- May 2, 2014 · Class II · Z-1727-2014: Alere initiated this recall because a limited number of Alere Triage¿ D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected d
- May 22, 2012 · Class I · Z-1932-2012: Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative result

## Indications for use
The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.

Source page: https://510kreport.com/device/K042890
Methodology: https://510kreport.com/methodology