(345 days)
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
The Elecsys Myoglobin Immunoassay includes two applications of the same reagents with different incubation times of 18 minutes (Myoglobin assay) and 9 minutes (Myoglobin STAT assay). The assay is a two-step sandwich immunoassay, using two different monoclonal antibodies directed against human Myoglobin, with streptavidin microparticles, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.
The acceptance criteria for the Elecsys Myoglobin Immunoassay and Elecsys Myoglobin STAT Immunoassay, along with the reported device performance, are detailed below. The study proves the device's substantial equivalence to a predicate device (Elecsys Myoglobin STAT assay K983176), rather than establishing new clinical effectiveness. Therefore, the information regarding multi-reader multi-case studies, expert adjudication, and detailed ground truth establishment for novel device performance is not fully applicable in the context of a 510(k) submission for substantial equivalence based on performance characteristics.
1. Table of Acceptance Criteria and the Reported Device Performance
| Feature | Acceptance Criteria (Predicate: Elecsys Myoglobin STAT assay K983176 Performance) | Reported Device Performance (Elecsys Myoglobin and Myoglobin STAT) |
|---|---|---|
| Measuring Range | 15-3000 ng/mL | 21-3000 ng/mL |
| Expected values (Men) |
§ 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).