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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.
Requires a manufacturer to comply with labeling
regulations
- 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)
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