(184 days)
The Coag-A-Mate MTX is a multipurpose system for use in performing in-vitro coagulation studies, clot based and chromogenic.
Automated system for in vitro coagulation studies, clot based and chromogenic.
The provided text describes the Coag-A-Mate MTX, a multipurpose system for in vitro coagulation studies. Here's a breakdown of the acceptance criteria and study details based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in a quantitative format before presenting the results. Instead, it presents performance metrics and compares them to typical system performance and NCCLS recommendations, implying these form the basis of acceptance.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation with Predicate Device | High correlation (e.g., r > 0.95) | Clot-based screening assays: r = 0.954 - 0.994 |
| Clot-based quantitative assays: r = 0.988 - 0.995 | ||
| Chromogenic assays: r = 0.954 | ||
| Total Imprecision (CV) | Well within NCCLS recommendations | Clot-based screening assays: |
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.