# K042423: Verifynow-Aspirin Assay

- Pathway: 510(k) (Special)
- Applicant: Accumetrics, Inc.
- Decided: Oct 6, 2004 after 29 days
- Product code: JOZ (System, Automated 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
Longest line of descent: 1 generation back to K830749 (1983). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830749: Platelet Aggregometer, Chrono-Log Corp. (1983) Summary page 1.

## Most influential descendants
- K122162: Aggreguide (2013), 1 descendant of its own
- K163274: AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument (2017), 0 descendants of its own
- K062025: Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136 (2007), 0 descendants of its own

## Indications for use
The VerifyNow Aspirin Assay is a qualitative assay to aid in the detection of platelet dysfunction due to aspirin ingestion in citrated whole blood for the point of care or laboratory setting. This assay is not for use in patients with underlying congenital platelet abnormalities, patients with non-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin anti-platelet agents (may be used in patients treated with selective COX-2 inhibitors, e.g., celecoxib (Celebrex®) and rofecoxib (Vioxx®).

Source page: https://510kreport.com/device/K042423
Methodology: https://510kreport.com/methodology