(27 days)
CDS 3-PD Hematology Controls are intended to serve as a means of verifying the results obtained from a hematology analyzer system. This material applies to hematology analyzer systems equipped to measure RBC count and size, WBC count and size, PLT count and size, total HGB concentration, and calculated parameters HCT, MCH, MCHC, RDW, WBC percent and number for lymphocyte, mononuclear and granulocyte populations. The products are designed to be sampled directly into the analyzer system as a sample specimen with minimal operator intervention.
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The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the "CDS 3-PD Hematology Controls" device. This letter indicates that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices.
However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. The 510(k) pathway for medical device clearance primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and detailed performance studies like a PMA (Premarket Approval) application would.
Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed scientific study demonstrating performance against specific acceptance criteria.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.