# K983460: Star Automated Multi-Parametric Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Nov 12, 1998 after 43 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- 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 K942117 (1995). 1 ancestor in all.
6 later devices descend from it; 2 cite 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)
- K942117: Sta Automated Multi-Parametric Analyzer, American Bioproducts Co. (1995) Summary page 1.

## Most influential descendants
- K082675: Sta-R Evolution Automated Multi-Parametric Analyzer (2008), 3 descendants of its own
- 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
- K082248: Sta Satellite Automated Multi-Parameter Analyzer (2008), 1 descendant of its own
- K253658: STA Satellite Max® (2026), 0 descendants of its own

## Recalls of this device
- Mar 5, 2003 · Not classified · Z-0899-03: With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.

## Indications for use
STA-R® Automated Multi-Parametric Analyzer 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/K983460
Methodology: https://510kreport.com/methodology