(30 days)
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.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.