(17 days)
The MAS™ CardioImmune TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific assayed control bornmontions. Include MAS™ Cardiolmmune TL with patient cardrac mance delemination for any of the listed constituents. Assay values scrant specific the specific systems listed. The user can compare observations are provided for the eas a means of assuring consistent performance of reagent and instrument.
The DADE® Cardiac TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific assured oonly of our an of any and e DADE® Cardiac TL with patient serum carolac manel determinations: "In of the listed constituents. Assay values are Specifichs when assuring for any any any can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Not Found
The provided text is a 510(k) premarket notification approval letter from the FDA for MAS™ CardioImmune TL Level 1, 2 and 3 and DADE® Cardiac TL Level 1, 2, and 3. These devices are classified as Quality Control Material (Assayed and Unassayed).
The document does not contain the information requested about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Instead, the document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device meets the same performance and safety standards as existing devices on the market, usually demonstrated through comparison with those predicates rather than entirely new studies with specific acceptance criteria and detailed performance reporting as requested.
Therefore, I cannot provide the requested information based on the given text.
§ 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.