# K961579: Sta Compact Automated Multi-Parametric Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Jul 10, 1996 after 77 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- Recalls of this device: 3 (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.
3 later devices descend 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)
- K942117: Sta Automated Multi-Parametric Analyzer, American Bioproducts Co. (1995) Summary page 1.

## Most influential descendants
- K093167: Sta Compact Automated Multi-Parametric Analyzer (2009), 2 descendants of its own
- K130090: Sta Compact Max (2013), 1 descendant of its own
- K212183: STA R Max 3, STA Compact Max 3 (2023), 0 descendants of its own

## Recalls of this device
- Jul 30, 2007 · Not classified · Z-0039-2008: Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error mess
- Jan 18, 2007 · Not classified · Z-0812-2007: Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.
- 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
The STA Compact® instrument is a fully automated laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Source page: https://510kreport.com/device/K961579
Methodology: https://510kreport.com/methodology