(264 days)
The Personal Fluid Sample Retrieval System is for over-the-counter distribution and is a device for collection and transportation of serum for in vitro diagnostic quantitative determination of cholesterol, triglycerides, glucose, HDL cholesterol and calculated LDL cholesterol. The serum sample is transferred in a transport pouch to the testing laboratory and results are returned directly to the consumer.
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This document is a 510(k) clearance letter from the FDA for a device called "Personal Fluid Sample Retrieval System". It does not contain information about acceptance criteria or specific study details proving a device meets those criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.
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The provided text focuses on the regulatory clearance of a medical device and does not include the detailed technical study information required to answer your questions about acceptance criteria and device performance studies.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.