# K081008: Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Dec 22, 2008 after 256 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: 2 (0 Class I)
- 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.
2 later devices descend 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)
- K040316: Cedia Buprenorphine Assay, Microgenics Corp. (2004) Summary page 2.

## Most influential descendants
- K090844: Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and Controls (2009), 1 descendant of its own
- K253082: LZI Buprenorphine II Enzyme Immunoassay (2026), 0 descendants of its own

## Recalls of this device
- Feb 18, 2014 · Class III · Z-1270-2014: Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP 
- Oct 3, 2013 · Class III · Z-0386-2014: Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.

## Indications for use
The Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay, when used in conjunction with Beckman Coulter® Synchron LX®, CX®, and UniCel® DxC automated clinical system analyzers, is intended for the qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine, at a cutoff value of 10 ng/mL. 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 with Beckman Coulter® Synchron LX®, CX®, and UniCel® DxC automated clinical system analyzers. 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 with Beckman Coulter® Synchron LX®, CX®, and UniCel® DxC automated clinical system analyzers. 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/K081008
Methodology: https://510kreport.com/methodology