(295 days)
Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures as measured by a change in platelet count due to activation of functional platelets. It may be used at the point-of-care on the Ichor hematology analyzer as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.
Plateletworks is a unitized screening assay for determining platelet aggregation in a whole blood sample using the Ichor hematology analyzer. The Plateletworks methodology is an adaptation of platelet aggregometry that is extremely simple, and quick to perform (results are available in about five minutes). This method involves using the Ichor hematology analyzer (based on electronic impedance principles) to measure total platelet count in a whole blood sample and then to redetermine the number of platelets in a second sample that has been exposed to a known platelet agonist. The agonist will stimulate those platelets which are functional to aggregate into clumps, and they will not be counted as platelets in the second sample. The difference in platelet counts between samples one and two provides a direct measurement of platelet aggregation and is reported as percent aggregation as per the following equation: Baseline Platelet Count - Agonist Platelet Count x 100 = % Aggregation Baseline Platelet Count
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strong positive correlation with predicate device (PRP Aggregometry) for ADP-induced platelet aggregation. | Pearson r = 0.83*, Spearman Rho = 0.68*, Kendall Tau = 0.50* (for ADP) |
| Strong positive correlation with predicate device (PRP Aggregometry) for Collagen-induced platelet aggregation. | Pearson r = 0.82*, Spearman Rho = 0.80*, Kendall Tau = 0.58* (for Collagen) |
| Ability to measure platelet aggregation in fresh whole blood samples. | Demonstrated through the study comparing Plateletworks with PRP aggregometry using fresh whole blood samples. |
| Suitable for use as an in vitro diagnostic screening assay. | The strong correlations support its use as a screening tool in the clinical setting. |
*P
§ 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).