(155 days)
The MS 9/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential count for In-Vitro diagnostic use in clinical laboratories.
Not Found
The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets the acceptance criteria for the MS 9/5 Hematology Analyzer. The document is primarily a 510(k) clearance letter from the FDA, confirming substantial equivalence to a predicate device for marketing purposes. It states the device's indications for use but does not delve into the specific performance study details, acceptance criteria, or ground truth establishment.
Therefore, I cannot provide the requested information based on the given input.
What is available from the text:
- Device Name: MS 9/5 Hematology Analyzer
- Indications for Use: The MS 9/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential count for In-Vitro diagnostic use in clinical laboratories.
§ 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.”