(141 days)
The AMAX Destiny™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
The AMAX Destiny™ Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX Destiny™ Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX Destiny™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III) and for microparticle agglutination assays such as d-dimer.
The provided document is a 510(k) summary for the AMAX Destiny™ Coagulation Analyzer. It focuses on demonstrating substantial equivalence to a predicate device (AMAX 190™ Coagulation Analyzer) through performance comparisons, specifically regression statistics and precision studies. Since this is a submission for an in-vitro diagnostic device (an analyzer), the typical acceptance criteria and study designs for imaging AI/ML devices (which involve human readers, ground truth establishment by experts, etc.) are not directly applicable.
However, I will extract relevant information and reframe it to align with the spirit of your request to the best of my ability, highlighting what "acceptance criteria" and "study" mean in this context.
1. Table of Acceptance Criteria and Reported Device Performance
For this in-vitro diagnostic device, "acceptance criteria" are implicitly defined by the demonstration of "substantial equivalence" to the predicate device, the AMAX 190™ Coagulation Analyzer. The performance metrics are regression statistics (correlation coefficient 'r' indicating linearity/agreement, and the regression equation 'y = mx + b' indicating bias and slope) and precision (within-run and total coefficients of variation).
| Test | Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|---|
| PT (optical) | Correlation (r) | High correlation (e.g., typically >0.9) | 0.993 |
| PT (optical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.223x - 1.5 |
| PT (mechanical) | Correlation (r) | High correlation | 0.994 |
| PT (mechanical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.180x - 2.5 |
| APTT (optical) | Correlation (r) | High correlation | 0.913 |
| APTT (optical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.191x - 1.2 |
| APTT (mechanical) | Correlation (r) | High correlation | 0.923 |
| APTT (mechanical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.112x - 2.3 |
| Factor IX (optical) | Correlation (r) | High correlation | 0.977 |
| Factor IX (optical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 0.928x + 3.8 |
| Factor IX (mechanical) | Correlation (r) | High correlation | 0.964 |
| Factor IX (mechanical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 0.880x + 3.9 |
| Factor X (optical) | Correlation (r) | High correlation | 0.982 |
| Factor X (optical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 0.935x + 3.3 |
| Factor X (mechanical) | Correlation (r) | High correlation | 0.972 |
| Factor X (mechanical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 0.957x + 2.5 |
| Fibrinogen (optical) | Correlation (r) | High correlation | 0.978 |
| Fibrinogen (optical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 0.974x + 27.3 |
| Fibrinogen (mechanical) | Correlation (r) | High correlation | 0.968 |
| Fibrinogen (mechanical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.069x - 14.5 |
| Thrombin time (mechanical) | Correlation (r) | High correlation | 0.990 |
| Thrombin time (mechanical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 0.965x + 1.5 |
| AT III (chromogenic) | Correlation (r) | High correlation | 0.934 |
| AT III (chromogenic) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.070x - 8.8 |
| D-dimer (agglutination) | Correlation (r) | High correlation | 0.995 |
| D-dimer (agglutination) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.121x - 57.0 |
| Precision Studies - Within Run Coefficient of Variation | Typically |
§ 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.