(135 days)
Coamatic® Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen (Plg) activity in human citrated plasma on automated laboratory equipment and also using microplate and manual methods. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.
Coamatic® Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen (Plg) activity in human citrated plasma on automated laboratory equipment and also using microplate and manual methods.
The provided document describes the Coamatic® Plasminogen device, an in vitro diagnostic test for plasminogen activity. The study presented is a method comparison study between the new Coamatic® Plasminogen and the predicate device, Coatest® Plasminogen, rather than a separate device performance study with specific acceptance criteria that are explicitly stated in a table.
However, based on the information provided, we can infer the acceptance criteria and then list the reported performance.
Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation (r) to predicate device, typically > 0.90 for quantitative assays, across various instruments and methods. | Correlation (r) to Coatest® Plasminogen: |
- ACL 300 (n=59): 0.92
- Cobas Mira S (n=41): 0.97
- Cobas Bio (n=30): 0.97
- Cobas Fara (n=30): 0.97
- EPOS 5060 (n=32): 0.99
- MLA (n=37): 0.98
- Test tube method (n=23): 0.92
- Microplate method (n=31): 0.93 |
| Precision (Within-run) | Low Coefficient of Variation (CV) for reproducibility, typically
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).