# K200197: ARK Fentanyl II Assay

- Pathway: 510(k) (Traditional)
- Applicant: Ark Diagnostics, Inc.
- Decided: Feb 26, 2020 after 30 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001178 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180427: ARK Fentanyl Assay, Ark Diagnostics, Inc. (2018) Summary page 4.

## Indications for use
The ARK Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 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 ARK Fentanyl II Assay provides only a preliminary analytical 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/K200197
Methodology: https://510kreport.com/methodology