# K061803: Sta - Control LA 1+2

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago, Inc.
- Decided: Jul 28, 2006 after 31 days
- Product code: GGC (Control, Plasma, Abnormal)
- 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: 1 generation back to K952623 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952623: Cryo Check Lupus Plasma, Precision Biologicals, Inc. (1995) Summary page 1.

## Most influential descendants
- K142132: Pool Norm (2014), 0 descendants of its own

## Indications for use
The STA -R - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of the tests for LA detection carried out with the following tests: STA® -Staclott dRVV Screen (#00339 & #00333) STAR® -Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)

Source page: https://510kreport.com/device/K061803
Methodology: https://510kreport.com/methodology