(27 days)
MAS® T-Marker Control is intended for use in the clinical laboratory as a quantitative. control for monitoring test procedures used to assay human serum for tumor markers. Include T-Marker Control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
DADE® Special-T Marker® Control is intended for use in the clinical laboratory as a quantitative control for monitoring test procedures used to assay human serum for tumor markers. Include Special-T Marker® Control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Not Found
The provided text is an FDA 510(k) clearance letter for a quality control material (MAS® T-Marker, Level 1, 2 and 3 and DADE® Special-T Marker®, Level 1, 2 and 3). It states that the device is "substantially equivalent" to legally marketed predicate devices.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot extract the requested information from this document. The sections you asked for, such as a table of acceptance criteria and reported performance, sample sizes, ground truth details, expert qualifications, adjudication methods, or MRMC/standalone studies, are not present.
§ 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.