(66 days)
A blood collection kit for D.N.A. is a device intended for medical purposes to collection tubes. A blood collection kit for D.N.A. is a device may include blood collection tubes, vials, systems, or vacuum sample tubes.
A blood collection kit for D.N.A. is a device intended for medical purposes to collection tubes. A blood collection kit for D.N.A. is a device may include blood collection tubes, vials, systems, or vacuum sample tubes.
I apologize, but the provided text describes a 510(k) clearance letter for a DNA Blood Collection Kit and does not contain information about acceptance criteria or a study proving device performance as requested. It is a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the input provided.
§ 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.