Quality standards

Why have FDA clearance?

Requires a manufacturer to comply with regulations

Encourages higher quality in products Enforces Good Manufacturing Practices (GMP)

• FDA can inspect a facility every 2 years.

• Performance characteristics claim
• Accuracy and precision
• Correlation with other methods
• Specificity
• Principles and limitations of procedure
• Specimen collection and handling
• Assay procedures
• Warnings and precautions
• Interpretation of results
• Quality control

510(k) letter for Varian OnTrak TesTcup® and OnTrak TesTstik® (96 kb pdf)

510(k) letter for OnTrak TesTcup® II and On-Site® CupKit™ products (312 kb pdf)