# K033137: Potens +

- Pathway: 510(k) (Traditional)
- Applicant: Wada, Inc.
- Decided: Dec 8, 2003 after 69 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: 2 generations back to K813564 (1982). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962857: Coag-a-Mate MTX, Organon Teknika Corp. (1997) Summary page 1.
- K924453: Multi-Channel Discrete Analyzer (Mda-180), Organon Teknika Corp. (1992) Summary page 1.

## Indications for use
POTENS+ is an in vitro medical device to determine the coagulation profile of citrated human plasma specimens to be used by a medical professional in a laboratory setting. This profile includes Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR). Prothrombin Time is used to determine the status of the extrinsic clotting pathway for Clotting Factors I, II, V, VII and X, and to assist in monitoring oral anticoagulants. Fibrinogen is used to diagnose disseminated intravascular coagulation (DIC), as a representation of acute disease - part of the "acute phase response," and it is an independent risk variable in heart attack and stroke prediction. INR is used to monitor the patients receiving anticoagulation therapy.

Source page: https://510kreport.com/device/K033137
Methodology: https://510kreport.com/methodology