(84 days)
The Amelung KC 4 A Micro Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests. Any clotting time test that has fibrin formation as its endpoint may be performed on the KC 4 A.
The Amelung KC 4 A Micro Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests.
The provided text describes performance testing for the Amelung KC 4 A Micro Coagulation Analyzer, a semi-automated mechanical clot detection system. However, specific acceptance criteria are not explicitly stated in a defined table or section. Instead, the study aims to demonstrate substantial equivalence to predicate devices and acceptable precision.
Here's an analysis of the available information:
1. Table of "Acceptance Criteria" and Reported Device Performance
Since explicit acceptance criteria are not provided, I will interpret "acceptable limits" for precision and strong correlation coefficients for method comparison as the implied criteria for substantial equivalence.
| Performance Metric | Implied Acceptance Criterion (Inferred) | Reported Device Performance | Comments |
|---|---|---|---|
| Method Comparison (Correlation with Reference/Predicate Devices) | Correlation coefficient (r) close to 1, and regression equation (y = mx + b) where m is close to 1 and b is close to 0 (indicating good agreement) | See detailed results below | The reported r values are generally high, indicating strong correlation. |
| Precision | "Within acceptable limits" (for beta sites); Coefficient of Variation (CV) |
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.