# K013078: Actalyke Mini Activated Clotting Time Test System, Model 5750/5752

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Jan 10, 2002 after 118 days
- Product code: JBP (Activated Whole Blood Clotting Time)
- Device class: 2
- Regulation: 21 CFR 864.7140
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Nov 9, 2020 · Class II · Z-0635-2021: Due to complaints received associated with cracked/split test tube caps.

## Indications for use
ActalykeR MiniTM Activated Clotting Time (ACT) Test System is used to perform the activated clotting time test, a whole blood coagulation assay commonly used to monitor heparin anticoagulation during various medical and surgical procedures. This unit is designed to be used in a point-of-care environment.

Source page: https://510kreport.com/device/K013078
Methodology: https://510kreport.com/methodology