# K141406: Immunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine Controls and Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Jul 1, 2014 after 34 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: 2 generations back to K001178 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040316: Cedia Buprenorphine Assay, Microgenics Corp. (2004) Summary page 1.

## Indications for use
Immunalysis Buprenorphine Urine Enzyme Immunoassay: The Immunalysis Buprenorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 5ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Buprenorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Buprenorphine. This in-vitro diagnostic device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Immunalysis Buprenorphine Urine Enzyme Immunoassay Kit 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 Spectroscopy (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 Buprenorphine Urine Controls: The Immunalysis Buprenorphine Urine Controls are used as control materials in the Immunalysis Buprenorphine Urine Enzyme Immunoassay. Immunalysis Buprenorphine Urine Calibrators: The Immunalysis Buprenorphine Urine Calibrators are used as calibrators in the Immunalysis Buprenorphine Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Buprenorphine in urine on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K141406
Methodology: https://510kreport.com/methodology