(420 days)
The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. For in vitro diagnostic use. For professional use only.
The VerifyNow System is a turbidimetric-based optical detection system that measures plateletinduced aggregation. The system consists of an instrument, a disposable test device and quality control materials. Quality control measures include an instrument based electronic quality control (EOC). two levels of wet quality controls (WOC), internal quality controls, and shipping controls. The instrument controls all assay sequencing, temperature, reagent-sample mixing and performs self-diagnostics. The degree of platelet function is determined and the result is displayed.
The VerifyNow PRUTest device contains three lyophilized reagent pellets in separate reaction chambers within the test device: 1) ADP pellet consisting of a preparation of Fibrinogen and BSA coated beads, adenosine-5-diphosphate (ADP), prostaglandin E1 (PGE1), dye, buffer, and a preservative; 2) TRAP pellet (Internal Control) consisting of a preparation of iso-TRAP (Thrombin Receptor Activating Peptide), Fibrinogen and BSA coated beads, buffer, dye, and a preservative; and 3) No-Agonist Pellet (NAP) consisting of a preparation of BSA coated beads, dye, buffer, and a preservative.
The provided text describes the performance studies for the VerifyNow PRUTest device, demonstrating its substantial equivalence to a predicate device (VerifyNow P2Y12 Assay).
Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list a single table of "acceptance criteria" for all tests, but rather describes the criteria within the context of each study. Below is a compilation of the criteria and performance for the key studies described:
| Study/Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison | Slope not statistically significantly different from 1.0; Intercept not statistically significantly different from 0; Correlation (r) greater than 0.9. | P2Y12 Rep 1 vs. PRUTest Rep 1: Slope = 1.01 (95% CI: 0.97–1.05), p-value = 0.56; Intercept = -0.77 (-8.00-6.50); Correlation R = 0.98. |
| P2Y12 Avg. vs. PRUTest Avg.: Slope = 1.04 (95% CI: 1.00-1.07), p-value = 0.07; Intercept = -4.57 (-11.2-2.05); Correlation R = 0.98. | ||
| Performance met criteria. | ||
| Precision (WQC Level 1) | PRU result ≤ 30 (indicates negative control/no aggregation). | All WQC Level 1 results fell within the acceptable range of ≤ 30 PRU. At the nine-month time point, the range of PRU values generated with WOC Level 1 did not exceed 30 PRU. |
| Precision (WQC Level 2) | Within-run, Between-run, Between-day, Between-lot, and Total %CVs for WQC Level 2 (specific values are not given as general acceptance criteria, but implied by the successful analysis against CLSI EP05-A2). For stability, Percent recovery ≥ 90 to ≤ 110% of baseline PRU. | Between-lot: Total SD = 22.2, Total %CV = 7.4. |
| Between instrument: Total SD = 24.2, Total %CV = 8.0. | ||
| For stability, percent recovery of WQC Level 2 passed acceptance criterion (≥ 90 to ≤ 110%) at nine months. | ||
| Precision (Whole Blood - Multiple Lot) | Individual CVs for Within-run, Between-run, Between-day, Between-lot components each |
§ 864.5700 Automated platelet aggregation system.
(a)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.(b)
Classification. Class II (performance standards).