# K163274: AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument

- Pathway: 510(k) (Special)
- Applicant: Aggredyne, Inc.
- Decided: Apr 5, 2017 after 135 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: 3 generations back to K830749 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122162: Aggreguide, Aggredyne, Inc. (2013) Summary page 4.

## 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-100 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 years of age or older in 3.2% citrated venous whole blood using the AggreGuide A-100 instrument. For professional use. This test 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. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.

Source page: https://510kreport.com/device/K163274
Methodology: https://510kreport.com/methodology