# K092258: Randox Metabolite (Eddp) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Nov 9, 2010 after 469 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
Randox Methadone Metabolite (EDOP) Assay The Randox Laboratories Ltd. Methadone Metabolite Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/mI for EDDP. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of EDDP use or overdose. The Randox Methadone Metabolite Assay has been developed for use on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GOMS or (2) permitting laboratories to establish quality control procedures. This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatographlmass spectrometry (GCIMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. Randox EDDP Calibrator Set The Randox EDDP Calibrator Set consists of liquid calibrators containing EDOP. There are 5 levels of calibrator. They have been developed for use in the calibration of EDDP assays on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only. Randox EDOP Controls, Level 1 & 2 The Randox EDDP Controls, level 1 and 2 are liquid controls containing EDDP. There are 2 levels of controls. They have been developed for use in the quality control of the EDOP assay on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K092258
Methodology: https://510kreport.com/methodology