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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK120015 Summary

Traditional 510(k) Summary

A)SUBMITTED BY/:
SPONSOR:
NanoEnTek, Inc.
300 Washington St, STE 416
Newton, MA, 02458, USA
   
 CONTACT:Sharyn Orton, PhD
MEDicept Inc.
200 Homer Ave
Ashland, MA 0 1721
401-330-8264
508-231-8861 Fax
B)DEVICE NAME:ADAM- rWBC
   
 COMMON NAME:Automatic Cell Counting System
   
 DEVICE CLASS:21 CFR 864.5220, Automated Differential Cell Counting System
Class II
   
 PRODUCT CODE:GKZ

C) PREDICATE:

  • Becton Dickinson Leucocount Kit (BK970046) tested on Becton Dickinson FACS flow cytometer

D) DEVICE DESCRIPTION:

T'he ADAM-rWBC consists of an LED fluorescence microscope system and CCD detector encased in a portable unit. There is also microfluid chip technology and associated reagents. The system is designed for counting residual white blood cells (rWBCs) in leukoreduced blood products. The principle of the system consists of measuring stained nuclei from disrupted cells treated with lysing agent and Propidium Iodide.

The ADAM-rWBC consists of the following components:

  • The ADAM-rWBC microscopic cell counting device
  • ADAM-rWBC kit containing the r-Slide, r-Solution and Standard beads solution

E) INTENDED USE/INDICATIONS FOR USE:

The ADAM-rWBC system is intended for in vitro use for the enumeration of residual white blood cells (rWBCs) in leukoreduced blood products.

F) SUBSTANTIAL EQUIVALENCE COMPARISON AND DISCUSSION

 ADAM- rWBCBD Leucocount Kit
BK970046
Intended Use
Indication for Use
For in vitro diagnostic use for the enumeration of residual leukocytes in leukoreduced blood products.For in vitro diagnostic use for the enumeration of residual leukocytes in leukoreduced blood products.
Method of
identification
Nucleic acid dye (Propidium Iodide) for leukocyte staining. Enumeration of residual WBCs using a portable microscopic cell counter.Nucleic acid dye (Propidium Iodide) for leukocyte staining. Enumeration of residual WBCs using a flow cytometer.
InstrumentMicrochannel chip inserted into microscopic cell counter and scanned optically using a green LED (532 nm).A flow cytometer equipped with 488 nm air-cooled argon ion laser for fluoresence exitation.
SoftwareCalculation of residual WBCs per µL and automatically displayed.Manual discrimination of residual WBCs and manual calculation of results.
CalibrationCalibrator check at start-up and at least once a day.None
Linear range0-100 WBCs/µL1-350 WBCs/µL
Accuracy
 
 
 RBCSlope= 1.010
Intercept= 0.299
r2 = 0.989
Slope= 0.993
Intercept= 5.364
r2 = 0.942
 PlateletSlope 1.027
Intercept= 1.066
r2 = 0.989
Slope= 1.044
Intercept= 2.433
r2 = 0.940

G) OTHER PERFORMANCE TESTING

Sample Stability
RBC samples obtained for testing may be held for 24 hours at 1-8°C prior to testing.
Platelet samples obtained for testing may be held for 24 hours at 1-8°C or room temperature prior to testing.

Stained Sample Stability
Stained samples may be held at room temperature for up to one hour prior to testing.

H) OTHER- Compliance with Standards

There are no applicable performance Standards or Guidance documents associated with this device. The ADAM-rWBC complies with:

  • Electrical Safety- EN 61010-1:2001 Safety requirements for electrical equipment for measurement, control and laboratory use, General requirements.
  • EMC-EN 61326-1:2006 .Electrical equipment for measurement, control and laboratory use. EMC requirements. General requirements
  • LED- IEC 62471:2006 Photobiological safety of lamps and lamp systems

I) CONCLUSION

The ADAM-rWBC and BD Leucocount have the same indications for use, use the same nucleic acid stain and have similar performance characteristics. The difference in the technical method of enumeration of residual WBCs does not raise new issues of safety or effectiveness because the scientific methods to test the performance of the ADAM-rWBC have demonstrated it to be substantially equivalent to the predicate device, and that it performs as required for its intended use.