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The IDS-iSYS IGF-I Controls Set is a quality control material device intended for medical purposes for use in the IDS-iSYS Insulin like Growth Factor-I (IGF-I) Assay on the IDS-iSYS Multi-Discipline Automated Analyser to monitor the accuracy and quality of the IDS-iSYS IGF-I Assay.

The IDS-iSYS IGF-I Controls Set is a quality control material device.

The provided document is an FDA 510(k) clearance letter for a quality control material device. It primarily focuses on regulatory approval and does not contain the detailed study information required to answer the questions about acceptance criteria and device performance as typically found in a clinical study report.

Therefore, I cannot extract the requested information from the provided text. The document does not describe:

• Acceptance criteria and reported device performance in a table.
• Sample sizes, data provenance, number of experts for ground truth, adjudication methods, details of MRMC studies, standalone performance, type of ground truth used, or training set information.

This document confirms regulatory clearance for a "Quality Control Material (Assayed and Unassayed)" device, meaning it is used to monitor the accuracy and quality of another assay, not to diagnose or treat patients directly. As such, the typical clinical efficacy study format (with test sets, ground truth, expert adjudication, etc.) would not apply in the same way it would for a diagnostic or therapeutic device.

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