# K051231: Verifynow-P2Y12 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Accumetrics, Inc.
- Decided: Aug 5, 2005 after 84 days
- Product code: JOZ (System, Automated Platelet Aggregation)
- Device class: 2
- Regulation: 21 CFR 864.5700
- Recalls of this device: 3 (0 Class I)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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
- K141427: Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest (2015), 1 descendant of its own
- K181777: AggreGuide A-100 ADP (2019), 0 descendants of its own

## Recalls of this device
- Feb 6, 2012 · Class II · Z-1854-2012: The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Te
- Feb 6, 2012 · Class II · Z-1853-2012: The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Te
- Sep 5, 2006 · Not classified · Z-0228-2007: The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.

## Indications for use
The VerifyNow-P2Y1 2 Assay is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y1 2 receptor blockade.

Source page: https://510kreport.com/device/K051231
Methodology: https://510kreport.com/methodology