(14 days)
IMMULITE® Turbo Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of myoglobin in serum or heparinized plasma. It is intended strictly for in vitro use as an aid in the diagnosis of acute myocardial infarction (AMI).
IMMULITE® Turbo Myoglobin is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer.
The provided document is limited to the 510(k) summary and the FDA's clearance letter for the IMMULITE® Turbo Myoglobin device. It does not contain information about the specific studies, acceptance criteria, or performance data that would typically be detailed in a more comprehensive submission or scientific publication. As such, I cannot provide the requested information based on the given text.
The document only states:
- "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE® Turbo Myoglobin."
This indicates that some data were submitted and reviewed, but the specifics of that data (acceptance criteria, study design, sample sizes, etc.) are not included in this summary.
§ 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).