# K122162: Aggreguide

- Pathway: 510(k) (Traditional)
- Applicant: Aggredyne, Inc.
- Decided: Dec 20, 2013 after 518 days
- Product code: JOZ (System, Automated Platelet Aggregation)
- Device class: 2
- Regulation: 21 CFR 864.5700
- Recalls of this device: 1 (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)
- K042423: Verifynow-Aspirin Assay, Accumetrics, Inc. (2004) Summary page 1.

## Most influential descendants
- K163274: AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument (2017), 0 descendants of its own

## Recalls of this device
- Jul 23, 2019 · Class II · Z-1639-2022: The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this issue, the targe

## Indications for use
The AggreGuide A-i 00 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 yearn of age or older in 3.2% citrated venous whole blood using the AggreGuide A-i 00 instrument. For professional use. This test is not for use in patients with underlying congenital platelet abnormalities, patients with nan-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin anti-platelet agents. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.

Source page: https://510kreport.com/device/K122162
Methodology: https://510kreport.com/methodology