# K061991: Plateletworks Arachidonic Acid, Model PW-Aca

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Feb 23, 2007 after 225 days
- Product code: GHR (Reagent, Platelet Aggregation)
- Device class: 2
- Regulation: 21 CFR 864.5700
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Plateletworks Arachidonic Acid (PW-ACA) is an in vitro diagnostic screening test on whole blood for the qualitative determination of platelet inhibition by aspirin which inhibit arachidonic acid induced platelet aggregation. The change in platelet count due to activation and aggregation of functional platelets is measured using an electronic impedance-base cell counter.

Source page: https://510kreport.com/device/K061991
Methodology: https://510kreport.com/methodology