# K161216: Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Jun 14, 2017 after 411 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: 3 generations back to K001178 (2000). 3 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150606: Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive, Siemens Healthcare Diagnostics, Inc. (2015) Summary page 4.

## Most influential descendants
- K180427: ARK Fentanyl Assay (2018), 19 descendants of its own
- 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

## Indications for use
The Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 1.0 ng/mL. The assay is intended for use in laboratories for the qualitative analysis of Fentanyl in human urine with automated clinical chemistry analyzers. This assay is calibrated against Fentanyl. This in vitro diagnostic device is for prescription use only. The Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. Immunalysis Fentanyl Urine Calibrators: The Immunalysis Fentanyl Urine Calibrators are used as calibrators in the Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay for the qualitative determination of Fentanyl in urine on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K161216
Methodology: https://510kreport.com/methodology