A Meprobamate Test System is a device that measures the amount of meprobamate in a human sample. It can be used to detect the presence of meprobamate in blood, urine, or plasma

Intended Use of Meprobamate Test System

A Meprobamate Test System is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally related drug compounds (e.g., prodrugs).

Intended Use:

It is a homogenous enzyme immunoassay for the qualitative analysis of carisoprodol metabolite, Meprobamate in human urine. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only

Device Description:

The homogenous enzyme immunoassay device for detecting Meprobamate, a metabolite of Carisoprodol, in human urine is designed for use with automated clinical chemistry analyzers in laboratory settings. This in vitro diagnostic test is intended for prescription use only and provides a qualitative result, indicating the presence or absence of Meprobamate metabolites in urine. The assay utilizes enzyme-labeled antibodies that react with the target metabolite, generating a detectable signal, typically a color change or fluorescence. It is commonly used in drug screening, monitoring, and forensic toxicology to confirm Carisoprodol use or abuse. The device ensures high sensitivity and specificity, minimizing cross-reactivity with other substances in urine.

Performance Testing (Analytical) for Meprobamate Test System

• Precision/Reproducibility
• Linearity/assay reportable range
• Detection Limit
• Analytical Specificity
• Interference

Clinical Testing

No Guidance available for 510k submission