(23 days)
The MAS® CardioImmune® TL is intended for use in the clinical laboratory as an assayed control scrum suitable for monitoring assay conditions in specific cardiac marker determinations. Include this product 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.
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The provided text is a 510(k) clearance letter from the FDA for a cardiac marker control device. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets performance criteria in the way a diagnostic or AI-driven device would. The device, "MAS® CardioImmune® TL Liquid Assayed Cardiac Marker Control Level 1, 2 and 3," is a quality control material intended for use in clinical laboratories to monitor assay conditions for cardiac marker determinations.
Therefore, I cannot provide the requested information for acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of information is not typically part of a 510(k) clearance letter for a quality control material.
The letter primarily focuses on:
- Substantial equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
- Device classification: Class I.
- Intended Use: "intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations."
The clearance process for a quality control material like this primarily involves demonstrating that it performs as intended for quality control without significant safety or effectiveness concerns, often through comparisons to existing, similar products rather than extensive clinical efficacy trials as you would see for a diagnostic test.
§ 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.