SYSMEX XE-5000 - Page 224

CHAPTER 11 Technical Information
11-6 Sysmex XE-5000 Instructions for Use
Revised July 2007
Linearity
Whole blood mode
WBC Within ±2.0% or ±0.2 × 10
3
/µL (0.00 – 100.00 × 10
3
/µL)
Within ±6.0% (100.01 – 310.00 × 10
3
/µL)
Within ±11.0% (310.01 – 440.00 × 10
3
/µL)
WBC-D Within ±2.0% or ±0.2 × 10
3
/µL (0.00 – 100.00 × 10
3
/µL)
Within ±6.0% (100.01 – 310.00 × 10
3
/µL)
Within ±11.0% (310.01 – 440.00 × 10
3
/µL)
RBC Within ±2.0% or within ±0.03 × 10
6
/µL (0.00 – 8.00 × 10
6
/µL)
HGB Within ±2.0% or ±0.2 g/dL (0.0 – 25.0 g/dL)
HCT Within ±2.0% or ±1.0 HCT% (0.0 – 75.0 HCT%)
PLT Within ±5.0% or within ±10 × 10
3
/µL (0 – 2000 × 10
3
/µL)
Within ±6.0% (2001 – 5000 × 10
3
/µL)
(the value may not fall within the above ranges, depending on RBC
concentration)
RET% Within ±20% or ±0.3 RET% (0.00 – 23.00%)
RET# Within ±20% or within ±0.015 × 10
6
/µL (0.0000 – 0.7200 × 10
6
/µL)
NRBC% Within ±20% (0.0 – 464.0/100 WBC)
NRBC# Within ±2.0% or within ±2.0 × 10
3
/µL (0.00 – 19.20 × 10
3
/µL)
Linearity
Capillary mode
WBC Within ±4.0% or within ±0.4 × 10
3
/µL (0.00 – 440.00 × 10
3
/µL)
RBC Within ±4.0% or within ±0.06 × 10
6
/µL (0.00 – 8.00 × 10
6
/µL)
HGB Within ±5.0% or ±0.5 g/dL (0.0 – 25.0 g/dL)
HCT Within ±4.0% or ±2.0 HCT% (0.0 – 75.0 HCT%)
PLT Within ±10.0% or within ±20 × 10
3
/µL (0 – 5000 × 10
3
/µL)
(the value may not fall within the above ranges, depending on RBC
concentration)
Linearity
Body fluid analysis
mode
WBC-BF Within ±10/uL ( 0 – 0.050 × 10
3
/µL )
Within ±20% ( 0.050 – 10.000 × 10
3
/µL )
RBC-BF Within ±2.0% or within ±0.010 × 10
6
/µL(0.000 – 5.000 × 10
6
/µL)
Linearity Range*
1
HPC# 0.000 – 0.500 × 10
3
/µL
Linearity is performed by analyzing a series of dilutions and taking multiple
measurements of each dilution. Samples should be diluted with CELLPACK and
measured immediately after each dilution is made.
*1: Guidance for Premarket Notification for Automated Differentlel Cell Counters for
Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.
Document issued: November 1, 2000. CDRH, FDA.
Note:
This specification is based on the verification using control blood.