# K964716: Sta Liatest Control [N]+[P] Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Jun 26, 1997 after 213 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
No predicates in its family tree.
7 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K030182: Liquichek D-Dimer Control, Model 356, 357 (2003), 6 descendants of its own
- 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

## Indications for use
The STA® Liatest® Control [N]+[P] kit is intended for use as control plasmas (Normal and Abnormal levels) for von Willebrand Factor (vWF) and D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).

Source page: https://510kreport.com/device/K964716
Methodology: https://510kreport.com/methodology