(220 days)
PlasmaCon N is a human lyophilized plasma control intended for use as a normal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.
PlasmaCon L-1 is a human lyophilized plasma control intended for use as a mid-level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.
PlasmaCon L-2 is a human lyophilized plasma control intended for use as a high level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.
The PlasmaCon Control Plasma devices contain lyophilized citrated human plasma, for use in the verification of system performance for PT and aPTT assays.
Here's a breakdown of the acceptance criteria and study information for the PlasmaCon N, PlasmaCon L-1, and PlasmaCon L-2 devices, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Within-run %CV |
§ 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.