# K161316: George King Coumadin Plasma

- Pathway: 510(k) (Traditional)
- Applicant: George King Bio-Medical, Inc.
- Decided: Feb 23, 2017 after 288 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 K971219 (1997). 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)
- K971219: Cryo Check Inr Validation Set, Precision Biologicals, Inc. (1997) Summary page 4.

## Indications for use
The George King Coumadin® Plasma is an assayed control plasma derived from a single donor on Coumadin® therapy and is intended for in vitro diagnostic use in monitoring the accuracy of the coagulation analyzer and thromboplastin using the clottable prothrombin time/INR on an optical instrument with appropriate commercial reagents. George King Coumadin® Plasma may be used when evaluating a new lot of thromboplastin reagent or new coagulation analyzer. The intended users of the George King Coumadin® Plasma are trained laboratory personnel working in clinical laboratories.

Source page: https://510kreport.com/device/K161316
Methodology: https://510kreport.com/methodology