# K082675: Sta-R Evolution Automated Multi-Parametric Analyzer

- Pathway: 510(k) (Special)
- Applicant: Diagnostica Stago, Inc.
- Decided: Oct 10, 2008 after 25 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- 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: 2 generations back to K942117 (1995). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983460: Star Automated Multi-Parametric Analyzer, American Bioproducts Co. (1998) Summary page 1.

## Most influential descendants
- K093001: Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric Analyzer (2009), 2 descendants of its own
- K151867: Sta R Max (2015), 1 descendant of its own
- K212183: STA R Max 3, STA Compact Max 3 (2023), 0 descendants of its own

## Indications for use
The STA-R® Evolution/Expert Series is a fully automatic clinical instrument designed for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Source page: https://510kreport.com/device/K082675
Methodology: https://510kreport.com/methodology