(14 days)
SASTM hCG Serum Controls are intended to be used to monitor the performance and accuracy of SASTM pregnancy test kits. These controls are for professional use only.
SAS™ hCG Serum Controls
This document is an FDA 510(k) clearance letter for a device named "SAS™ hCG Serum Controls." It primarily addresses regulatory approval and provides a brief "Indications For Use" statement.
Based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This document is a regulatory approval notice, not a study report.
Therefore, I cannot provide a table or answer the specific questions about the study design and results. The document only confirms the device's intended use:
Indications For Use:
SASTM hCG Serum Controls are intended to be used to monitor the performance and accuracy of SASTM pregnancy test kits. These controls are for professional use only.
§ 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.