# K964728: Sta-Liatest D-DI Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Jun 26, 1997 after 213 days
- Product code: DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K862156 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862156: Asserachrom D-DI Kit, American Bioproducts Co. (1986) Summary page 1.

## Most influential descendants
- K141144: Sta Liatest D-DI (2014), 0 descendants of its own

## Recalls of this device
- Sep 12, 2025 · Class II · Z-0205-2026: A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

## Indications for use
The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579) to perform quantitative determinations of D-dimer antigen levels in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.

Source page: https://510kreport.com/device/K964728
Methodology: https://510kreport.com/methodology