NOVA BIOMEDICAL StatStrip 55848 - 2 Quality Control; When to Perform a QC Test; Statstrip Glucose Control Solution

2-1
2. QC
Instructions for Use Manual 2 QC
2 Quality Control
2.1 When to Perform a QC Test
The StatStrip Glucose Hospital Meter includes several quality
control mechanisms that detect errors due to system failures
and operator performance. External controls materials are
available from Nova Biomedical for verifying the integrity
of the StatStrip Glucose Hospital Meter. These StatStrip
Glucose Control Solutions consist of 3 levels of ready-to-
use liquid controls. They are formulated at clinically relevant
levels. The controls can be used as part of a laboratory
quality control program. Run the controls according to the
procedure in Section 2.3 Quality Control Test.
2.2 StatStrip Glucose Control Solution
Read the StatStrip Glucose Control Solution
package insert sheet for complete instructions,
indications, precautions, and limitations of the
system.
Only the StatStrip Glucose Control Solutions are
recommended for use with the StatStrip Glucose Meter and
the StatStrip Glucose Test Strips. Ranges for the StatStrip
Glucose Meter using other commercially available glucose
controls have not been established and may give erroneous
results. Run 2 different levels of the StatStrip Glucose Control
Solutions during each 24 hours of testing prior to testing of
patient specimens and under the following circumstances:
• Each new operator
• BeforeusingtheStatStripMeterforthersttime
• If a patient test has been repeated and the blood
glucose results are still lower or higher than expected
• If there are other indications that the system is not
working properly
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 1 9/13/18 8:29 AM