(267 days)
HemosIL D-Dimer HS 500 Controls are assayed, human-sourced controls intended for the quality control of the HemosIL D-Dimer HS 500 assay as performed on the ACL TOP Family System, in a clinical laboratory setting. The controls are intended for in vitro diagnostic use.
Level 1 D-D HS 500 Control is intended for the assessment of the assay around the clinical cutoff for VTE (500 ng/mL FEU).
Level 2 D-D HS 500 Control is intended for the assessment of precision and accuracy of the assay at abnormal D-Dimer levels (above the cut-off).
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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter for the HemosIL D-Dimer HS 500 Controls, outlining its intended use and regulatory information. It does not contain details about specific performance studies, sample sizes, ground truth establishment, or expert reviews.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.