# K082248: Sta Satellite Automated Multi-Parameter Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago, Inc.
- Decided: Dec 12, 2008 after 126 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942117 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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.
- K021162: Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation Analyzer-Refurbished, Sigma Diagnostics, Inc. (2002) Summary page 1.

## Most influential descendants
- K253658: STA Satellite Max® (2026), 0 descendants of its own

## Recalls of this device
- Jul 21, 2025 · Class II · Z-2473-2025: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Jun 15, 2012 · Class II · Z-0252-2013: Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the po

## Indications for use
The SatelliteTM 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/K082248
Methodology: https://510kreport.com/methodology