# K152961: VALIDATE D-Dimer Calibration Verification/Linearity Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Company, LLC
- Decided: Jun 3, 2016 after 240 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: 5 generations back to K964716 (1997). 5 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K100716: Audit Microcv D-Dimer Linearity Set, Model K717M-5, Aalto Scientific, Ltd. (2011) Summary page 4.

## Most influential descendants
- 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
VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit solutions are an assayed quality control materials intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte: D-Dimer in a clinical laboratory setting by laboratory personnel. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.

Source page: https://510kreport.com/device/K152961
Methodology: https://510kreport.com/methodology