LZI Buprenorphine II Enzyme Immunoassay

The LZI Buprenorphine II Enzyme Immunoassay is a homogeneous enzyme immunoassay for qualitative and semi-quantitative detection of norbuprenorphine in human urine at a 5 ng/mL cutoff. It uses a competition-based method where enzyme activity decreases upon binding to antibody, measured spectrophotometrically at 340 nm. The assay is designed for prescription use on automated clinical chemistry analyzers and provides preliminary results requiring confirmation by LC/MS or GC/MS.

The device is a two-reagent liquid ready-to-use system containing mouse monoclonal anti-norbuprenorphine antibody with glucose-6-phosphate and NAD cofactors in R₁, and glucose-6-phosphate dehydrogenase labeled with norbuprenorphine in R₂. It uses the same enzyme immunoassay principle, reagent form, and platform as the predicate device (k090844), with identical storage requirements and detection methodology.

Not stated in this summary. The document references validation using LC/MS as a confirmatory method and mentions a modified NCCLS-EP5 protocol for precision testing, but does not cite specific consensus standards such as ISO, IEC, or ASTM.

Substantial equivalence is established because the device is compared to the legally marketed LZI Buprenorphine Enzyme Immunoassay (k090844) in terms of intended use, method principle, device components, and clinical performance. Verification and validation activities including method comparison with LC/MS, precision studies, cross-reactivity evaluation, and interference testing demonstrate the modified device performs substantially equivalent to the predicate for detecting norbuprenorphine in urine.