(13 days)
Pacific Hemostasis Coagulation Control Level 3 is intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing. It will yield PT and APTT values in the markedly abnormal range.
Pacific Hemostasis Coagulation Control Level 3 (Abnormal) is a lyophilized preparation of citrated plasma obtained from healthy donors, which has been adjusted to yield prolonged Prothrombin Time and Activated Partial Thromboplastin Time values. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Coagulation Control Level 3 (Abnormal) device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it compares the performance of the new device (Pacific Hemostasis Coagulation Control Level 3) directly against a legally marketed predicate device (Dade Ci-Trol Coagulation Control Level III) to establish substantial equivalence. The implication is that if the new device performs similarly to the predicate device within reasonable bounds, it meets the "acceptance criteria" for substantial equivalence.
Based on the "Summary of Performance Data for Substantial Equivalence Comparisons," the implicit acceptance criteria are that the new device should demonstrate comparable precision (CV%) to the predicate device for both Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) measurements.
| Performance Metric | Acceptance Criteria (Implicit, based on predicate) | Reported Device Performance (Pacific Hemostasis) | Predicate Device Performance (Dade) |
|---|---|---|---|
| Between-run Precision (PT) | 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.