# K182779: ARK EDDP Assay

- Pathway: 510(k) (Traditional)
- Applicant: Ark Diagnostics, Inc.
- Decided: Nov 21, 2018 after 51 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
Longest line of descent: 3 generations back to K931780 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151395: Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets, Immunalysis Corporation (2015) Summary page 4.

## Indications for use
The ARK EDDP Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of EDDP in human urine at cutoff concentrations of 100 ng/mL and 300 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only. The semiquantitative mode is for the purpose of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method, such as Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS), or (2) permitting laboratories to establish quality control procedures. The ARK EDDP Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed positive analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.

Source page: https://510kreport.com/device/K182779
Methodology: https://510kreport.com/methodology