FDA 510K for Myoglobin Immunological Test System
A Myoglobin Immunological Test System is a medical device that uses immunological techniques to measure the level of myoglobin in a patient’s blood or urine, allowing for the detection of muscle damage by identifying the presence of this protein which is released from injured muscle cells; essentially, it’s a test that uses antibodies to specifically detect myoglobin, helping to diagnose conditions like heart attack or rhabdomyolysis (severe muscle damage) by analyzing the amount of myoglobin present in a sample
Intended Use of Myoglobin Immunological Test System
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.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Myoglobin Immunological Test System
FDA 510K for Myoglobin Immunological Test System Device Code and Regulation Number
| S.
No |
Product
Code |
Device | Regulation Description | Regulation Number | Class |
| 1. | DDR | Myoglobin, Antigen, Antiserum, Control | Myoglobin Immunological Test System | 866.5680 | 2 |
Myoglobin, Antigen, Antiserum, Control
Intended Use:
Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of heart or renal disease.
Device Description:
A device designed for biological analysis often includes components such as a myoglobin detection system, which is used to measure myoglobin levels in a sample, typically for clinical diagnostics of muscle damage or heart conditions. The system may also incorporate an antigen detection feature, which allows for the identification of specific foreign substances, such as pathogens or allergens, by triggering an immune response. To facilitate the detection process, the device often uses antiserum, a serum containing antibodies that bind to the target antigens, helping to pinpoint their presence. Finally, a control is integrated into the device to ensure the accuracy of the results. The control serves as a baseline for comparison, verifying that the device is functioning correctly and that the observed changes are due to the test conditions rather than other variables. Together, these elements enable precise biological analysis in clinical, research, or diagnostic settings.
Performance Testing (Analytical) for Myoglobin Immunological Test System
- Precision/Reproducibility
- Linearity/assay reportable range
- Detection limit
- Analytical specificity
- Traceability, Stability, Expected Values (Controls, Calibrators, or Methods)
Clinical Testing:
No Guidance available for 510k submission