# K103555: Multiplate 5.0 Aggregometer

- Pathway: 510(k) (Traditional)
- Applicant: Verum Diagnostica GmbH
- Decided: Jul 27, 2012 after 602 days
- Product code: JOZ (System, Automated Platelet Aggregation)
- Device class: 2
- Regulation: 21 CFR 864.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K830749 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050265: Chrono-Log Whole Blood Lumi-Aggregometer, Model 700, Chrono-Log Corp. (2005) Summary page 1.

## Indications for use
The ADPtest reagent is a lyophilized preparation of adenosine-5-diphosphate for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only. The ASPItest reagent is a lyophilized preparation of arachidonic acid (AA) for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only. For use as an assayed quality control verification of the resistance measure of impedance aggregometry.

Source page: https://510kreport.com/device/K103555
Methodology: https://510kreport.com/methodology