| 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: |
STELLer CD34 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 STELLer CD34 have been developed to detect CD34+ cells in peripheral blood and apheresis products. |
| Intended Use: |
The STELLer CD34 Assay is intended for the use with IMAGN 2000 Microvolume Fluorimeter to determine the concentration of CD34+ cells in peripheral blood and apheresis products. |
| Comparison |
STELLer CD34 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 Data: |
Biometric Imaging produced data addressing the range, precision, sensitivity of the STELLer CD34 Assay. |
| Clinical Data: |
Field trials at two clinical sites showed that the STELLer CD34 Assay when used with the IMAGN2000 Microvolume Fluorimeter compares favorably to flow cytometry and provides the advantages of automation. |
| Conclusion |
STELLer CD34 Assay when used with the IMAGN 2000 Microvolume Fluorimeter accurately and precisely determines the concentration of CD34+ cells in peripheral blood and apheresis products. |
