# K012318: Randox Therapeutic Drug Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Sep 12, 2001 after 51 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- 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 Therapeutic Drug Calibrators are based on lyophilised human serum and have been developed for use in the calibration of therapeutic drug assays. The constituent concentrations of the Randox Laboratories Limited Therapeutic Drug Calibrator are present at 6 levels. The Randox Laboratories Limited Therapeutic Drug Calibrator should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K012318
Methodology: https://510kreport.com/methodology