# K012319: Randox Human Asssayed Drug Control

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Aug 24, 2001 after 32 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- 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 Limited Drug Controls (Levels I, II and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically therapeutic drug monitoring. These control materials are available at three constituent concentrations. The Randox Human Drug Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K012319
Methodology: https://510kreport.com/methodology