# K141427: Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest

- Pathway: 510(k) (Traditional)
- Applicant: Accumetrics, Inc.
- Decided: Jul 24, 2015 after 420 days
- Product code: JOZ (System, Automated Platelet Aggregation)
- Device class: 2
- Regulation: 21 CFR 864.5700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K830749 (1983). 2 ancestors in all.
1 later device descends 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)
- K051231: Verifynow-P2Y12 Assay, Accumetrics, Inc. (2005) Summary page 4.

## Most influential descendants
- K181777: AggreGuide A-100 ADP (2019), 0 descendants of its own

## Recalls of this device
- Oct 21, 2025 · Class III · Z-0500-2026: Due to an device without a premarket clearance being incorrectly package and distributed.
- Mar 30, 2022 · Class II · Z-1121-2022: Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed a

## Indications for use
The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. For in vitro diagnostic use. For professional use only.

Source page: https://510kreport.com/device/K141427
Methodology: https://510kreport.com/methodology