Search Results

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.

Ask a specific question about this device