(71 days)
The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.
The Myoglobin reagents. Myoglobin calibrators, the Access Access Immunoassay Analyzer and the Access 2 Immunoassay Analyzer comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.
The document provided describes the Access Myoglobin assay. Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Consistent and reproducible results (low %CV) | - Within-run imprecision: 1.58%CV to 2.20%CV |
- Between-run imprecision: 2.34%CV to 4.24%CV
- Total imprecision: 3.03%CV to 4.54%CV |
| Analytical Sensitivity | Ability to detect low levels of Myoglobin (distinguishable from zero) | The lowest detectable level of Myoglobin distinguishable from zero (with 95% confidence) is
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).