(118 days)
The ATAC Serum Calibrator is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, direct bilirubin, glucose, iron, magnesium, phosphorus, total bilirubin, total protein, triglycerides, urea and uric acid in human specimens.
Not Found
The provided text is related to the FDA's 510(k) premarket notification for the ATAC Serum Calibrator. It outlines the regulatory approval for this device, which is intended for use with ATAC Clinical Systems to establish reference points for various analytes in human specimens.
However, the provided text does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert involvement. It is primarily a regulatory approval letter and an "Indications for Use" statement.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions about the study from the given input.
To answer your questions, I would need a document that describes the verification and validation studies performed for the ATAC Serum Calibrator, including:
- Specific performance metrics (e.g., accuracy, precision, linearity).
- The acceptance criteria for each metric.
- The results of the studies demonstrating that these criteria were met.
- Details about the study design, sample characteristics, and how ground truth was established.
§ 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.