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The Barbiturate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semiquantitative analyses of barbiturates in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.

Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

The Barbiturate Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-ofabuse test result, particularly when preliminary positive results are used.

The Barbiturate Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine.

The Barbiturate Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine.

LZI's Barbiturate Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect barbiturates in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.

The assay is based on competition between barbiturate labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.

All of the Single Analyte Urine DAU Calibrators and Controls are human urine-based liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. Each contains a known concentration of a specific drug analyte.

The Negative DAU calibrator is a processed, drug-free human urine matrix, which has also been used with all assays. The calibrators and controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix.

Here's a breakdown of the acceptance criteria and the study information for the Lin-Zhi International, Inc. Barbiturate Enzyme Immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria with specific thresholds for each performance metric. However, we can infer the acceptance criteria for the LZI device by comparing its performance to that of the predicate device (Syva EMIT® II Plus Barbiturate Assay). The goal is to show comparable or acceptable performance.

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