(125 days)
The CS-400™ 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 Amelung CS-400™ Coagulation Analyzer is an automated random access multipurpose analyzer. The CS-400™ 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 CS-400™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III).
The provided text describes the 510(k) summary for the Sigma Diagnostics Inc. CS-400™ Coagulation Analyzer. The acceptance criteria and the study proving the device meets them are detailed as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance characteristics from comparison studies and precision studies. The comparison studies establish the device's correlation with a predicate device, while precision studies demonstrate its reproducibility.
| Test (Method) | Acceptance Criteria (from comparison study with Amelung AMAX CS-190™) | Reported Device Performance (r-value) | Reported Device Performance (Regression Equation) | Acceptance Criteria (from precision study) | Reported Device Performance (Within Run CV) | Reported Device Performance (Total CV) |
|---|---|---|---|---|---|---|
| PT (optical) | N/A (regression statistics provided to show substantial equivalence) | r = 0.921 | y = 1.061x + 0.6 | ≤ (implied acceptable precision) |
§ 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.