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1. The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic test for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum.
2. The Roche Calibrator HDL Direct is intended for use as calibrator in quantitative High Density Lipoprotein Cholesterol (HDL CHOL) assays.

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This document is a 510(k) clearance letter for an in vitro diagnostic device (Roche UNIMATE HDL Direct Reagent and Roche Calibrator HDL Direct). It does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a summary of safety and effectiveness.

Therefore, I cannot extract the requested information regarding:

• Acceptance criteria and reported device performance table: This information is not present in the document.
• Sample size and data provenance for the test set: Not available.
• Number and qualifications of experts for ground truth: Not available.
• Adjudication method for the test set: Not available.
• MRMC comparative effectiveness study and effect size: Not available.
• Standalone algorithm performance: Not applicable as this is a reagent/calibrator, not an algorithm.
• Type of ground truth used: Not available.
• Sample size for the training set: Not applicable/available.
• How ground truth for the training set was established: Not applicable/available.

This document serves as notification that the device has been found substantially equivalent to a predicate device and can be marketed, but it does not provide the underlying study details.

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