# K040570: Randox Methadone Assay

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: May 10, 2004 after 67 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- 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
1 Methadone Assay The I methadone assay has been designed for use only on the 1 analyser for qualitative detection of methadone, a narcotic pain-relieving drug, in urine uing a cut-off concentration of 300 ng/mL. Qualitative results obtained can be utili~'ed in the diagnosis and treatment of methadone use or overdose. This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS. The 1 Methadone Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions. Evidence Drugs of Abuse Calibrators The Evidence Drugs of Abuse Calibrators are liquid Calibrators containing Methadone. There are 9 levels of calibrator. They have been developed for use in calibration of the 1 system. The Evidence Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K040570
Methodology: https://510kreport.com/methodology