# K030182: Liquichek D-Dimer Control, Model 356, 357

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Feb 24, 2003 after 38 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: 1 generation back to K964716 (1997). 1 ancestor in all.
6 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)
- K964716: Sta Liatest Control [N]+[P] Kit, American Bioproducts Co. (1997) Summary page 1.

## Most influential descendants
- K032017: Liquichek D-Dimer Control Level 1, 2 and 3 (2003), 5 descendants of its own
- K050799: Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer Controls (2005), 4 descendants of its own
- 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

## Indications for use
Liquichek D-dimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer. Methods: bioMerieux Vidas Dade Behring BCS/BCT -Advanced D-Dimer Dade Behring Stratus CS Dade Behring Sysmex Series -Advanced D-Dimer Diagnostica Stago Sta/Sta-R/Sta-Compact - LIATEST IL ACL Series Roche Cobas Integra 400/800 - Tina-quant Roche Hitachi - Tina-quant

Source page: https://510kreport.com/device/K030182
Methodology: https://510kreport.com/methodology