| Applicant: |
Biometric Imaging, Inc.
1025 Terra Bella Avenue
Mountain View, Ca. 94043-1829 |
| Contact: |
Thomas P. Hartz, Jr., Ph.D.
Vice President |
| Date Summary Prepared: |
May 14, 1997 |
| Device Trade Name: |
CEQer RBC Assay for use with the IMAGN 2000 Microvolume Fluorimeter |
| Common Name: |
Automated differential cell counter |
| Classification Name: |
Counter, cell, differential classifier, automated |
| Equivalent Device: |
IMAGN 2000 4T8 System
|
| Device Description: |
IMAGN 2000 Microvolume Fluorimeter is a cellular analysis Platform which enables the imaging and quantitation of cells in precisely defined volumes. The CEQer RBC have been developed to detect residual white blood cells in blood products. |
| Intended Use: |
CEQer RBC Assay is intended for the use with IMAGN Microvolume Fluorimeter to determine the concentration of residual white blood cells in leukocyte reduced red blood cell component. |
| Comparison |
CEQer RBC Assay when used with the IMAGN 2000 Microvolume Fluorimeter is substantially equivalent to the IMAGN 2000 4T8 System for imaging and quantifying specific cells in precisely define volumes.. |
| Nonclinical Performance Data: |
None provided at this time.. |
| Clinical Performance Data: |
Field trials at four clinical sites showed that the CEQer RBC Assay when used with the IMAGN 2000 Microvolume Fluorimeter compares favorably in accuracy and sensitivity to the Nageotte chamber method and provides the advantages of automation.. |
| Conclusion |
CEQer RBC Assay when used with the IMAGN Microvolume Fluorimeter accurately and precisely determines the concentration of residual white blood cells in leukocyte reduced platelet rich plasma. |
