# K041361: Randox Tri Level Cardiac Control

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Sep 9, 2004 after 111 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 Randox Laboratories Ltd. Tri-Level Cardiac Control (Level 1,11and Ill) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a Iml final re-constituted volume. The Randox Tri-Level Cardiac Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K041361
Methodology: https://510kreport.com/methodology