(22 days)
For the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDL Cholesterol and LDL Cholesterol in serum.
DMA's HDL Cholesterol and LDL Cholesterol calibrator is intended for the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDLC and LDLC in serum.
The provided document is a 510(k) summary for a medical device called "DMA HDL Cholesterol and LDL Cholesterol Calibrator." It describes the device's intended use and technological characteristics in comparison to a predicate device. However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes (for training or test sets), expert qualifications, or ground truth establishment relevant to the device's performance.
The document is a regulatory submission summarizing the device's purpose and its substantial equivalence to a predicate device for FDA clearance. It does not include the actual study data or the detailed acceptance criteria and performance results that would be part of a full study report.
Therefore, I cannot provide the requested information from this document.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.