(141 days)
The Sentinel Ceruloplasmin assay is used for the quantitation of ceruloplasmin (copper-transporting serum protein) levels in human serum or plasma. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorder.
Sentinel Ceruloplasmin is an in vitro diagnostic assay for the quantitative determination of ceruloplasmin in serum or plasma. The Sentinel Ceruloplasmin assay is a two-reagent format based on the immunological reaction between anti-ceruloplasmin antibonds specific for ceruloplasmin. The turbidity of the immunocomplex is proportional to the concentration of the analyte in the sample.
Here's an analysis of the provided text regarding the Sentinel Ceruloplasmin assay, broken down according to your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Sentinel Ceruloplasmin) |
|---|---|---|
| Method Correlation (Slope) | Close to 1.0 (indicating good agreement) | 1.0256 |
| Method Correlation (Y-intercept) | Close to 0 (indicating no systematic bias) | -1.0205 mg/dL |
| Total %CV (Precision) - Level 1 | Comparable to predicate (not explicitly stated, but generally |
§ 866.5210 Ceruloplasmin immunological test system.
(a)
Identification. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.(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 § 866.9.