(19 days)
The Quantimetrix Corp. Cardiasure Cardiac Markers Control is intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
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I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves a device meets these criteria. The document is a 510(k) clearance letter from the FDA for a device called "Quantimetrix Cardiac Markers Control," which is a quality control material.
The text describes:
- The FDA's decision that the device is substantially equivalent to legally marketed predicate devices.
- The regulatory classification of the device (Class I quality control material).
- General controls and potential additional controls if classified differently.
- The purpose of the device as stated in the "Indications for Use Statement," which is for monitoring serum cardiac analyte monitoring methods.
It does not contain any of the following requested information:
- A table of acceptance criteria or reported device performance.
- Sample sizes, data provenance, number or qualifications of experts for ground truth, or adjudication methods for test sets.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Details on the type of ground truth used or sample sizes/ground truth establishment for training sets.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided 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.