# K141144: Sta Liatest D-DI

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago
- Decided: Sep 3, 2014 after 124 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: 4 generations back to K862156 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964728: Sta-Liatest D-DI Test Kit, American Bioproducts Co. (1997) Summary page 4.
- K040882: Vidas D-Dimer Exclusion Assay, Model 30 442, bioMerieux, Inc. (2004) Summary page 4.

## 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 kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2% sodium citrate) for use on STA-R®, STA Compact® and STA Satellite® analyzers by professional laboratory personnel. The STA® - Liatest® D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and as an aid in the diagnosis of deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.

Source page: https://510kreport.com/device/K141144
Methodology: https://510kreport.com/methodology