# K050053: Hemoram/Aggram Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Jul 11, 2005 after 182 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AggRAM Analyzer is a 4-channel aggregometer designed to perform platelet aggregation and Ristocetin cofactor testing on patients for hemostasis abnormalities. Platelet aggregation studies are performed to quantitate platelet response and identify abnormal platelet function. The agonist, Ristocetin, can be used in the diagnosis of von willebrand's disease. Ristocetin Cofactor reagents are used to quantitate the von Willebrand factor activity.

Source page: https://510kreport.com/device/K050053
Methodology: https://510kreport.com/methodology