(69 days)
POTENS+ is an in vitro medical device to determine the coagulation profile of citrated human plasma specimens to be used by a medical professional in a laboratory setting. This profile includes Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR).
Prothrombin Time is used to determine the status of the extrinsic clotting pathway for Clotting Factors I, II, V, VII and X, and to assist in monitoring oral anticoagulants.
Fibrinogen is used to diagnose disseminated intravascular coagulation (DIC), as a representation of acute disease - part of the "acute phase response," and it is an independent risk variable in heart attack and stroke prediction.
INR is used to monitor the patients receiving anticoagulation therapy.
Semi-automated system for in vitro coagulation studies, clot based and photo-optical.
Here's a breakdown of the acceptance criteria and study information for the POTENS+ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabular format. Instead, it describes performance characteristics that demonstrated substantial equivalence to predicate devices. The key performance metrics are correlation coefficients (r-values) and precision (Coefficient of Variation - CVs).
| Performance Metric | Acceptance Criteria (from predicate equivalence) | Reported Device Performance (POTENS+) |
|---|---|---|
| Correlation Coefficients (r-values) | ||
| Fibrinogen | Not explicitly stated as acceptance criteria, but predicate equivalence was shown for values ≥ 0.973 (based on reported range) | 0.973 to 0.980 |
| PT | Not explicitly stated, but predicate equivalence was shown for values ≥ 0.95 (based on reported range) | 0.95 to 0.974 |
| INR | Not explicitly stated, but predicate equivalence was shown for values ≥ 0.919 (based on reported range) | 0.919 to 0.963 |
| Precision (Coefficient of Variation - CV) | ||
| Fibrinogen | NCCLS recommendations (CVs |
§ 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.