# K050799: Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer Controls

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jun 29, 2005 after 91 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K964716 (1997). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032017: Liquichek D-Dimer Control Level 1, 2 and 3, Bio-Rad (2003) Summary page 1.

## Most influential descendants
- K100716: Audit Microcv D-Dimer Linearity Set, Model K717M-5 (2011), 3 descendants of its own
- K152961: VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (2016), 2 descendants of its own
- K170864: VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (2017), 0 descendants of its own
- K162705: VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (2017), 0 descendants of its own

## Indications for use
The Triage D-Dimer Calibration Verification Controls are to be used with the Triage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimer Test throughout the measurable range. The Triage D-Dimer Controls are assayed materials to be used with the Triage D-Dimer Test and Triage MeterPlus to assist the laboratory in monitoring test performance.

Source page: https://510kreport.com/device/K050799
Methodology: https://510kreport.com/methodology