(69 days)
Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor) for the collection and stabilization of 2.5 mL whole blood prior to removal of plasma for total homocysteine measurement by HPLC for the detection of hyperhomocysteinæmia.
prescription use
Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor)
The provided text is a 510(k) clearance letter from the FDA for a blood collection tube (DS30 Hcy Blood Collection Tubes). It does not contain information on acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies typically associated with AI/ML-based medical devices or comparative effectiveness studies.
Therefore, I cannot fulfill the request as the provided document focuses on regulatory clearance for a blood specimen collection device and does not detail a study involving the criteria mentioned.
§ 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.