Methamphetamine Test System

Published On -

I3CGlobal IVDR, FDA 510k

FDA 510K for Methamphetamine Test System

The system involves a brief extraction from a urine sample with an Ad-Tip (ODS-silica Mini column), washing, eluting with modified Simon’s reagent, and coloration with carbonate buffer

Intended Use of Methamphetamine Test System

A Methamphetamine Test System is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are usedin the diagnosis and treatment of methamphetamine use or overdose.

For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Methamphetamine Test System 
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FDA 510K for Methamphetamine Test System Device Code and Regulation Number

S.No Product Code Device Regulation Description Regulation Number Device Class

1

LAF

 Gas Chromatography, Methamphetamine Methamphetamine Test System

862.3610

2

Gas Chromatography, Methamphetamine

Intended Use:

The system is intended for the qualitative and semi-quantitative analysis of methamphetamine in human oral fluid with clinical analyze

Device description:

Methamphetamine Oral Fluid Enzyme Immunoassay is an in-vitro diagnostic test designed to detect methamphetamine in human oral fluid samples. This test is calibrated against d-methamphetamine and utilizes a homogeneous enzyme immunoassay for qualitative and semi-quantitative analysis. Methamphetamine is a highly addictive stimulant drug, usually found as a white, bitter-tasting powder or pill. It can cause euphoria, increased energy, and alertness, but is also associated with severe side effects such as paranoia, tremors, appetite loss, mood swings, and neuropsychological impairments. Oral fluid has been shown to be a reliable matrix for detecting methamphetamine in various contexts, including compliance monitoring and legal cases like driving under the influence.

Performance Testing (Analytical) for Methamphetamine Test System

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

Clinical Testing

No Guidance available for 510k submission

 

 

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