The Phenobarbital Test System is designed to measure phenobarbital levels in serum or plasma, typically using a diagnostic platform. It works through a competitive immunoassay format, involving specific antibodies and enzyme conjugates to detect phenobarbital concentrations. This test aids in diagnosing and managing phenobarbital therapy and overdose cases.

Intended Use of Phenobarbital Test System

A Phenobarbitol Test System is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.

Intended Use

It measures phenobarbital (PHBR) concentration in serum and plasma (lithium heparin) using the Integrated System. These measurements are used as an aid in diagnosing, treating, and monitoring phenobarbital levels to ensure appropriate therapy and manage overdose situations. Rx Only, for in vitro diagnostic use and professional laboratory applications.

Device Description

It is a multilayered, analytical element coated on a polyester support, utilizing an enzymatic heterogeneous, competitive immunoassay format to measure phenobarbital concentration. Immobilized anti-phenobarbital antibody and phenobarbital-peroxidase conjugate are present in the spreading layer. The patient sample competes with a conjugate for antibody binding sites, and after washing, enzyme-mediated oxidation of a dye occurs. Dye formation is inversely proportional to phenobarbital levels, and a wash detection dye confirms adequate washing.

Performance Testing (Analytical)

• Precision (Reproducibility and Repeatability)
• Linearity
• Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ)
• Comparison studies
• Expected values
• Specificity
• Cross-Reactivity

Clinical Testing

No Guidance available  for 510k submission