(179 days)
The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only.
The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
The Diazyme Myoglobin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between myoglobin in a sample and anti-myoglobin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of myoglobin in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.
The Diazyme Myoglobin Assay's acceptance criteria and performance are detailed across sections of the provided document. The study primarily relies on method comparison and precision evaluations to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison | High correlation (R² close to 1) and a slope close to 1 with an intercept close to 0 when compared to the predicate device. | R² = 0.9855, Slope = 0.9526, Y-intercept = -4.2228. This is reported as correlating "well" with the predicate method. |
| Precision - Within-Run CV% | Not explicitly stated but generally expected to be low (e.g., typically |
§ 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).