(275 days)
Immunoturbidimetric assay for the quantitative in vitro determination of ceruloplasmin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device aid in the diagnosis of copper metabolism disorders.
The Tina-quant Ceruloplasmin assay employs an immunoturbidimetric test in which anti-ceruloplasmin antibodies react with antigen in the sample to form antigen/antibody complexes which, following agglutination can be determined turbidimetrically.
Here's a breakdown of the acceptance criteria and study information for the Tina-quant Ceruloplasmin Assay, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criterion | Criteria Value / Threshold | Reported Device Performance | Study Type to Demonstrate Performance (Implicit) |
|---|---|---|---|---|
| Precision (Repeatability) | Control Low | SD ≤ 0.4 mg/dL; CV ≤ 1.5% | SD 0.4 mg/dL; CV 1.5% | Internal Verification |
| Control High | SD ≤ 0.9 mg/dL; CV ≤ 0.9% | SD 0.9 mg/dL; CV 0.9% | Internal Verification | |
| Serum Low | SD ≤ 1.2 mg/dL, CV ≤ 1.2% | SD 1.2 mg/dL, CV 1.2% | Internal Verification | |
| Serum Medium | SD ≤ 0.5 mg/dL, CV ≤ 0.8% | SD 0.5 mg/dL, CV 0.8% | Internal Verification | |
| Serum High | SD ≤ 0.9 mg/dL, CV ≤ 0.8% | SD 0.9 mg/dL, CV 0.8% | Internal Verification | |
| Precision (Intermediate/Total) | Control Low | SD ≤ 0.4 mg/dL; CV ≤ 1.6% | SD 0.4 mg/dL; CV 1.6% | Internal Verification |
| Control High | SD ≤ 0.7 mg/dL; CV ≤ 1.1% | SD 0.7 mg/dL; CV 1.1% | Internal Verification | |
| Serum Low | SD ≤ 0.4 mg/dL, CV ≤ 1.6% | SD 0.4 mg/dL, CV 1.6% | Internal Verification | |
| Serum Medium | SD ≤ 0.7 mg/dL, CV ≤ 1.0% | SD 0.7 mg/dL, CV 1.0% | Internal Verification | |
| Serum High | SD ≤ 1.1 mg/dL, CV ≤ 0.9% | SD 1.1 mg/dL, CV 0.9% | Internal Verification | |
| Analytical Sensitivity | Limit of Blank (LoB) | ≤ 2 mg/dL | ≤ 2 mg/dL | Internal Verification |
| Limit of Detection (LoD) | ≤ 3 mg/dL | ≤ 3 mg/dL | Internal Verification | |
| Analytical Specificity | Interference (Common Drugs) | No interference at common therapeutic concentrations | No interference was found at common therapeutic concentrations using common drug panels. | Interference Study |
| Interferences (Recovery) | Icterus | Recovery within ±10% up to I-index 60 | No significant interference up to an I index of 60 (approx. 60 mg/dL conjugated/unconjugated bilirubin) | Interference Study |
| Hemolysis | Recovery within ±10% up to H-index 350 | No significant interference up to an H index of 350 (approx. 350 mg/dL hemoglobin) | Interference Study | |
| Lipemia | Recovery within ±10% up to L-index 400 | No significant interference up to an L Index of 400 mg/dL. | Interference Study | |
| Rheumatoid Factor (RF) | No interference up to RF |
§ 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.