(15 days)
The Triage® Cardiac Calibration Controls are controls used to assess the daily performance of the Triage® Cardiac Panel. These controls contain Myoglobin, Creatine Kinase MB and Troponin-I at three concentrations.
Not Found
The provided text is a 510(k) premarket notification approval letter for a medical device called "Triage® Cardiac Calibration Verification Controls." It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document primarily focuses on the FDA's decision regarding substantial equivalence.
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.