(190 days)
The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests.
The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the KC 40 Micro Coagulation Analyzer:
This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria. The "acceptance criteria" are implied by the comparison studies, where strong correlation and acceptable coefficients of variation indicate performance similar to existing, approved devices.
Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) submission, the "acceptance criteria" are not explicitly stated as distinct thresholds but are inferred from the comparison study results, demonstrating equivalence to predicate devices. The reported device performance is presented as regression statistics (r-values, slope, intercept) and coefficients of variation (CV%).
| Parameter | Implied Acceptance Criterion (e.g., strong correlation, low CV) | Reported Device Performance (vs. TOA CA-5000) | Reported Device Performance (vs. BBL Fibrometer) | Precision (Coefficient of Variation) |
|---|---|---|---|---|
| PT | Strong correlation, acceptable precision | r = 0.980, y = 1.123x + 0.616 | r = 0.980, y = 1.009x + 0.701 |
§ 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.