(98 days)
Plateletworks (K990398) 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 or Coulter hematology analyzers 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.
Automated Platelet Aggregation System
I am sorry, but there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) clearance letter from the FDA for the Plateletworks® device, indicating substantial equivalence to a predicate device and outlining regulatory information. It does not contain details about specific performance studies or acceptance criteria.
§ 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).