# K170864: VALIDATE D-Dimer Calibration Verification / Linearity Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Company, LLC
- Decided: Jun 21, 2017 after 90 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: 6 generations back to K964716 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152961: VALIDATE D-Dimer Calibration Verification/Linearity Test Kit, Maine Standards Company, LLC (2016) Summary page 5.

## Indications for use
VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit solutions are 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/K170864
Methodology: https://510kreport.com/methodology