# K100716: Audit Microcv D-Dimer Linearity Set, Model K717M-5

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Jun 23, 2011 after 468 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: 4 generations back to K964716 (1997). 4 ancestors in all.
3 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)
- K050799: Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer Controls, Biosite Incorporated (2005) Summary page 1.

## Most influential descendants
- 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 AuditTM MicroCVTM D-Dimer Linearity Set is a quantitative, assayed quality control material consisting of five levels of D-dimer analyte. The five D-dimer levels demonstrate a linear relationship to each other for D-dimer analyte. The AuditTM MicroCVTM D-Dimer Linearity Set is intended to use with the Biomerieux miniVIDAS® analyzer and VIDAS® D-dimer assay to verify the calibration of the measuring range. AuditTM MicroCVTM D-Dimer Linearity Set is "For In Vitro Diagnostic Use Only."

Source page: https://510kreport.com/device/K100716
Methodology: https://510kreport.com/methodology