# K212183: STA R Max 3, STA Compact Max 3

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago S.A.S
- Decided: Jun 7, 2023 after 694 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: 5 generations back to K942117 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151867: Sta R Max, Diagnostica Stago S.A.S (2015) Summary page 4.
- K130090: Sta Compact Max, Diagnostica Stago, Incorporated (2013) Summary page 4.

## Indications for use
The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Source page: https://510kreport.com/device/K212183
Methodology: https://510kreport.com/methodology