# K180427: ARK Fentanyl Assay

- Pathway: 510(k) (Traditional)
- Applicant: Ark Diagnostics, Inc.
- Decided: Jun 6, 2018 after 110 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: 4 generations back to K001178 (2000). 4 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161216: Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators, Immunalysis Corporation (2017) Summary page 4.

## Most influential descendants
- K220046: Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 (2022), 17 descendants of its own
- K231698: AllTest Fentanyl Rapid Test (Urine) (2023), 11 descendants of its own
- K233417: AllTest Fentanyl Urine Test Cassette (2023), 9 descendants of its own
- K240124: BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (2024), 2 descendants of its own
- K241969: Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel (2024), 1 descendant of its own

## Indications for use
The ARK Fentanyl 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 Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed 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/K180427
Methodology: https://510kreport.com/methodology