(40 days)
Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring various immunoassay and general chemistry assays.
Include Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 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
I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "CardioImmune Cardiac Marker Control Levels 1, 2, and 3". This document approves the device for market but does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a device already on the market, but it does not detail the specific performance metrics or studies directly validating its performance against acceptance criteria in the manner requested.
Therefore, I cannot provide the information you asked for based on the input 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.