(77 days)
The CELL-DYN® 4000 System with ImmunoPlt (CD61) Assay is a multi-parameter, automated. hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
The CELL-DYN® 4000 System with ImmunoPlt (CD61) Assay is a fully automated hematology analyzer, including reporting of the ImmunoPlt (CD61) count, intended for in-vitro diagnostic use in the clinical laboratory of a hospital, medical clinic, or reference laboratory.
The CELL-DYN® 4000 System has five main modules: the Analyzer, which aspirates, difutes and analyzes each whole blood specimen; the Autoloader, which automatically identifies, mixes, and presents specimens for processing; the Pneumatic Unit, which controls fluid movement in the Analyzer and tube movement in the Autoloader; the Data Station, which controls all system processing and provides the primary operator interface with the system; and the Color Printer, which generates reports automatically or on demand.
The CELL-DYN 4000 System with ImmunoPlt (CD61) Assay is designed to analyze EDTAanticoagulated whole blood specimens and report the hematological parameters shown in the table on the following page.
The provided text describes the CELL-DYN® 4000 System with ImmunoPlt™ (CD61) Assay, a multi-parameter automated hematology analyzer.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the "Equivalency Data" section "shows performance to manufacturer's specifications." However, the specific acceptance criteria (numerical thresholds) or the detailed reported performance values are not explicitly listed in the provided text. The text only broadly concludes that the data supports substantial equivalence to predicate devices and microscopy for low platelet counts.
| Parameter Category | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Summary) |
|---|---|---|
| Overall Performance | (Implied: Substantial equivalence to predicate devices and manual microscopy for platelet counts |
§ 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.”