(194 days)
The MS 4/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential for in vitro diagnostic use in clinical laboratories.
Not Found
The provided texts are from a 510(k) premarket notification for the MS 4/5 Hematology Analyzer, primarily containing the FDA's response and the Indications for Use statement. It does not contain the detailed acceptance criteria and study information that would typically be found in the manufacturer's submission for device performance.
Therefore, I cannot provide the requested information from these documents. To answer your questions, I would need the actual study report or the sections of the 510(k) submission that detail the performance testing and acceptance criteria for the MS 4/5 Hematology Analyzer.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”