# K090844: Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jul 30, 2009 after 125 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.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081008: Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems, Lin-Zhi International, Inc. (2008) Summary page 2.

## Most influential descendants
- K253082: LZI Buprenorphine II Enzyme Immunoassay (2026), 0 descendants of its own

## Indications for use
The Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine, at a cutoff value of 5 and 10 ng/mL. The assay is designed for prescription use in clinics and clinical chemistry laboratories with a number of automated clinical chemistry analyzers. The Norbuprenorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay. The Norbuprenorphine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive

Source page: https://510kreport.com/device/K090844
Methodology: https://510kreport.com/methodology