# K120014: Sta- Coag Control (N+Abn) Plus

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago, Inc.
- Decided: Mar 14, 2013 after 441 days
- Product code: GGN (Plasma, Coagulation Control)
- 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 K943518 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943518: Sta System Control [N] + [P] Kit, American Bioproducts Co. (1995) Summary page 2.

## Indications for use
The STA® - Coag Control (N + ABN) PLUS is a kit containing a normal plasma and an abnormal plasma intended for the quality control of the following tests on STA-R® and STA Compact® analyzers: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT).

Source page: https://510kreport.com/device/K120014
Methodology: https://510kreport.com/methodology