14
PERFORMANCE EVALUATIONS
PRECISION
Tests were carried by trained technicians in the
laboratory setting. The sample from one subject was
adjusted to 3 different levels. Strips out of a single lot
were tested. The results are shown in the following
table.
Level
No. of tests Mean (mg/dL ) Within-Run C.V. (%)
Low
Normal
High
20
20
20
43.3
96.2
381.0
4.7
3.4
2.4
ACCURACY
Tests were carried by trained technicians in the
laboratory setting. Samples from the subjects were
tested with both GlucCell Meter and YSI Model 2300
Glucose Analyzer as reference. The results are shown in
the following table.
Slope
1.07
y-intercept
-5.9 mg/dL; -0.3 mmol/L
Correlation Coefficient (R) 0.99
Number of tests
120
Range tested
54-490 mg/dL
3.0
–27.2 mmol/L
SYMBOL
Lot number
Do not reuse
Caution, consult
accompanying
document
Please consult
instructions for
use
Use by /Expiry date
EU
representative
Temperature
limitation / Store at
Manufacturer
This product fulfils the requirements of
Directive 98/79/EC in vitro diagnostic medical
device.
CONTACT INFORMATION
21 Changi South Street 1, 486777 Singapore
Tel:
+65 6542 0833
Fax: +65 6542 6920
E-mail: mail@vaccixcell.com
Website: www.vaccixcell.com
