# K181777: AggreGuide A-100 ADP

- Pathway: 510(k) (Traditional)
- Applicant: Aggredyne, Inc.
- Decided: Mar 29, 2019 after 269 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)
- K141427: Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest, Accumetrics, Inc. (2015) 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 ADP Assay is used with the AggreGuide A-100 instrument in non-CLIA waived physician’s office or clinical laboratory for the detection of platelet dysfunction in patients age 22 or older receiving P2Y 12 antiplatelet drugs, prasugrel and ticagrelor, using 3.2% sodium citrated whole blood. The AggreGuide A-100 ADP Assay is a semi-quantitative assay. The level of platelet aggregation is determined by the platelet activity index (PAI) where values < 4.7 PAI suggest that platelet dysfunction is due to the presence of P2Y 12 antiplatelet drugs, prasugrel and ticagrelor. The test results should be interpreted in conjunction with all other clinical and laboratory data available to the clinician.

Source page: https://510kreport.com/device/K181777
Methodology: https://510kreport.com/methodology