Search Results

A calibration or control fluid to be used in conjunction with The Binding Site range of turbidimetric/nephelometric grade (PN) antisera and The Binding Site MININEPH® range of products.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA, which confirms that a device (Turbidimetric/Nephelometric Human Complement Reference Preparation) is substantially equivalent to a legally marketed predicate device.

While it mentions the device and its indications for use, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets or training sets.
• Information on data provenance (country, retrospective/prospective).
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect sizes.
• Whether a standalone algorithm performance study was done.
• The type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for any training set was established.

This document focuses solely on the regulatory clearance based on substantial equivalence, not on the detailed technical studies that would establish specific performance metrics against acceptance criteria.

Ask a specific question about this device