# K991286: Avocet Acusure System

- Pathway: 510(k) (Traditional)
- Applicant: Avocet Medical, Inc.
- Decided: Nov 18, 1999 after 217 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- 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) Avocetpr: named in the summary without a submission number

## Indications for use
The Avocetpr.Home is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.

Source page: https://510kreport.com/device/K991286
Methodology: https://510kreport.com/methodology