# K980839: Avocet PT

- Pathway: 510(k) (Traditional)
- Applicant: Avocet Medical, Inc.
- Decided: Sep 30, 1998 after 210 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Boehringer Mannheim CoaguChek System: named in the summary without a submission number

## Indications for use
The Avocetpr is an in vitro diagnostic system that provides a quantitative prothrombin time result, expressed as an International Normalized Ratio (INR). It uses fresh capillary whole blood, citrated venous whole blood or citrated venous plasma samples. It is intended for use by health care professionals in monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy.

Source page: https://510kreport.com/device/K980839
Methodology: https://510kreport.com/methodology