Prime Blood Glucose Test Strips
™
™
IMPORTANT: Please read this insert and your ReliOn
INTENDED USE:
ReliOn™ Prime Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole
blood samples drawn from the fingertips or palm. ReliOn™ Prime test strips must be used with the ReliOn™
Prime Blood Glucose Meter. Testing is done outside the body (In Vitro Diagnostic Use). They are indicated
for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare
professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis
of or screening for Diabetes Mellitus and is not intended for neonates.
Test Principle:
Glucose in the blood sample mixes with chemicals on the test strip. This yields a small electrical current. The
ReliOn™ Prime Meter measures this current. It then shows the blood glucose result proportional to the current.
STORAGE AND HANDLING:
•
Store test strip containers in a cool, dry place between 39–86°F (4–30°C).
• Keep test strips away from direct sunlight and heat. Do not freeze or refrigerate.
• Do not store or transfer ReliOn™ Prime Test Strips outside of the original bottle.
• Do not bend, cut, or alter a ReliOn™ Prime Test Strip.
• As soon as you have removed a test strip, replace the cap securely on the bottle.
• When you first open the bottle, write the date on the bottle label. Use the test strips within 90 days (3
months) of first opening the bottle.
• Do not use test strips beyond the expiration date (
• Always clean and dry your hands before handling a test strip. Do not touch the sample application tip of the test strip.
• Do not use the test strip if it has been exposed to moisture. Any liquid on the test strip will cause inaccurate
readings, even if the liquid is wiped off or has dried.
• Do not re-use a ReliOn™ Prime Test Strip.
• Only use ReliOn™ Prime Test Strips with a ReliOn™ Prime Blood Glucose Meter.
Note: Healthcare Professionals should wear gloves when testing patient blood.
TEST PROCEDURE:
Materials provided:
ReliOn™ Prime Test Strips.
Materials required but not provided:
ReliOn™ Prime Meter.
User Instruction Manual. Lancing Device. Sterile Lancet.
Step 1
– Wash your hands in warm, soapy water. Rinse and dry thoroughly.
Step 2
– Insert a test strip to turn the meter on. Insert a test strip contact bars first, facing up.
Step 3
– Obtain blood sample. Apply blood to the end of test strip. Capillary action will pull the blood to the
reaction site. Add enough blood to the end of the test strip. The meter will begin to count down showing a
flashing dash. Discard the strip if the meter does not start to count down after a blood drop is applied.
Correct
Incorrect, Re-test
Step 4
– The meter will show a result in 7 seconds. The result will be automatically
stored in memory. The meter will automatically shut off when you remove the test strip.
IMPORTANT: The minimum sample volume is 0.5 µL. Smaller samples
may not start the meter or can start the meter count down and provide
an "E13" error message. Ensure blood completely fills reaction site.
IMPORTANT: Read the User Instruction Manual for more information
about test strips and how to test.
TEST RESULTS:
If your test result is lower than 20 mg/dL, the meter will show 'LO'.
If your test result is greater than 600 mg/dL, the meter will show 'HI'.
Seek medical assistance immediately if you obtain high or low results.
IMPORTANT: Follow all instructions fully. If you have symptoms that
are not consistent with your test result, call your healthcare professional.
RANGE OF EXPECTED VALUES:
Expected blood glucose levels for people without diabetes 1, 2 :
Fasting
70–110 mg/dL
2 hours after meals 70–140 mg/dL
WARNINGS AND PRECAUTIONS:
For In Vitro Diagnostic Use.
IMPORTANT: Low or high blood glucose readings can indicate a potentially
serious medical condition. If your blood glucose reading is unusually low or
1944-06
high, or you do not feel the way your readings indicate, repeat the test using
a new strip. If your result is still not consistent with your symptoms, or if your
blood glucose result is less than 60 mg/dL or higher than 240 mg/dL, contact
your diabetes healthcare professional for advice.
Never make significant changes to your diabetes control program or ignore
physical symptoms without consulting with your healthcare professional.
Severe dehydration (excessive water loss) may cause false low results. If you believe
you are suffering from dehydration, consult your healthcare professional immediately.
A red blood cell count (hematocrit) that is very high (above 52%) can give
abnormally low results. A very low hematocrit level (below 33%) can give
abnormally high results.
Inaccurate results may occur in severely hypotensive individuals or patients in shock.
1944-06
Inaccurate low results may occur for individuals experiencing a hyperglycemic-
hyperosmolar state, with or without ketosis. Critically ill patients should not be tested
with blood glucose meters.
Patients undergoing oxygen therapy may yield false results.
Healthcare professionals — please note additional limitations of procedure:
Triglycerides up to 3,300 mg/dL do not significantly affect test results. However, glucose
values in specimens beyond this triglycerides level should be interpreted with caution.
Metabolites of icodextrin (maltose, maltotriose and maltotetraose) do not significantly affect test results.
LIMITATIONS OF SYSTEM:
The ReliOn™ Prime Blood Glucose Monitoring System is not designed to substitute pathology laboratory
equipment and should not be used for the diagnosis of diabetes.
Use only fresh capillary blood. Do not use serum, plasma, or venous whole blood.
Do not use the ReliOn™ Prime Blood Glucose Monitoring System to test neonates; it has not been validated
for neonatal use.
ReliOn™ Prime Test Strips may be used at altitudes up to 10,000 ft (3,048 m) without effect.
IT IS RECOMMENDED TO CHECK YOUR SYSTEM USING CONTROL SOLUTION:
• When you open a new bottle of test strips.
• Whenever you suspect the meter or test strips may not be functioning properly.
• If test results appear to be abnormally high or low or are not consistent with clinical symptoms.
• If the test strip bottle has been left open or has been exposed to light, temperatures below 39°F (4°C) or
above 86°F (30°C), or humidity levels above 80%.
• To check your technique.
• When the ReliOn™ Prime Meter has been dropped or stored below 32°F (0°C) or above 122°F (50°C).
• Each time the battery is changed.
HOW TO CHECK YOUR SYSTEM WITH CONTROL SOLUTION:
See Control Solution insert for more information.
Step 1
– Insert a test strip into the meter. Be sure the contact bars go in first and face up.
Step 2
– Press the Back or Forward button to enter control solution mode.
Step 3
– Remove the cap from the control solution bottle. Place cap on a flat surface.
Squeeze the bottle and discard the first drop.
Step 4
– Apply the second drop to the top of the cap.
Step 5
– Bring the meter and strip to the drop, and allow the meter to test.
Step 6
– Compare the result to the acceptable range printed on the test strip bottle.
1 "Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia" World Health Organization, 2006
2 Diabetes Care, vol. 33 Jan:1 S82-86, 2010
™
Prime User Instruction Manual before testing.
) on the label.
Contact
Bars
Sample
Application
Tip
If the control solution results are out-of-range, repeat the test. Results that fall outside the range may be caused by any of
the following:
• The meter was not placed in control solution mode before adding solution – refer to manual or control solution insert.
• The control solution is expired or contaminated.
• The control solution was stored below 35°F (2°C) or above 86°F (30°C).
• The first drop of control solution was not discarded.
• The test strip was not stored correctly.
• The test strip was used after the expiration date on the bottle.
• The test strip bottle was open for more than 90 days (3 months).
• The ReliOn™ Prime Meter has been damaged or has malfunctioned.
• Contamination occurred due to the tip of the control solution bottle touching the test strip.
PLEASE NOTE:
If your Control Solution result continues to read outside the acceptable range, the system may not be working
DO NOT USE
correctly.
are unable to solve the problem, need help, or do not have control solution, please call Customer Service at
855.776.0662. Contact your diabetes healthcare professional if you cannot reach Customer Service.
REAGENT COMPOSITION:
Each ReliOn™ Prime Test Strip contains approximately:
Glucose Oxidase (Aspergillus niger sourced)
Hexaammineruthenium (III) Chloride
Non-reactive ingredients
PERFORMANCE CHARACTERISTICS FOR CONSUMERS:
ReliOn™ Prime performance has been evaluated both in laboratory and clinical tests. Diabetes experts have
suggested that glucose meters should agree within 15 mg/dL of a laboratory method when the glucose
concentration is lower than 75 mg/dL and within 20% of a laboratory method when the glucose concentration
is 75 mg/dL or higher. The chart below displays how often the ReliOn™ Prime Blood Glucose Monitoring System
achieves this goal. The chart is based on a study done to see how well the ReliOn™ Prime Blood Glucose
Monitoring System compared to laboratory results.
Fingertip results (professional clinical)
For glucose results lower than 75 mg/dL, the percent (and number)
of meter results that match the laboratory method within 15 mg/dL:
For glucose results at 75 mg/dL or higher, the percent (and number)
of meter results that match the laboratory method within 20%:
Total number of participants in study (tested in duplicate)
Alternate site results (professional clinical)
For glucose results lower than 75 mg/dL, the percent (and number)
of meter results that match the laboratory method within 15 mg/dL
For glucose results at 75 mg/dL or higher, the percent (and number)
of meter results that match the laboratory method within 20%
Total number of participants in study (tested in duplicate)
PERFORMANCE CHARACTERISTICS FOR PROFESSIONALS:
Precision:
Precision results indicate that, on average, you can expect a 2.8% variation from back-to-back testing across
a 44 - 306 mg/dL glucose range. The table shows Coefficient of Variation (CV%s) values for five glucose levels
that cover the glucose range typical of persons with diabetes. Values are averages from three separate lots of
test strips.
Mean Glucose Level (mg/dL)
44.1
83.0
131.3
181.9
306.0
Accuracy:
The
ReliOn™ Prime system was compared with a laboratory reference method. Testing was done both by
healthcare professionals and by persons with diabetes. The correlation coefficient (r) can vary between 0 and
1, where 1 indicates perfect accuracy. The 0.99 "r" value indicates a high correlation to the reference method.
This means that ReliOn™ Prime results will be very similar to results obtained on glucose analyzers used in
hospital and physician office laboratories.
Slope
Y-Intercept (mg/dL)
Correlation coefficient (r)
Number of subjects
1944-06
Range tested (mg/dL)
Professional Fingerstick Accuracy
Glucose results lower than 75 mg/dL (< 75 mg/dL)*
Range differences in values between the laboratory
results and the ReliOn
™
Prime
Blood Glucose Monitoring System
The number and percent of how many times
the results fell within the ranges listed above
Glucose results greater than or equal to 75 mg/dL ( ≥ 75 mg/dL)*
Range differences in values between the laboratory
results and the ReliOn
™
Prime
Blood Glucose Monitoring System
1944-06
The number and percent of how many times
the results fell within the ranges listed above
* Acceptance criteria in ISO15197 are that 95% of all differences in glucose values should be within 15 mg/dL for glucose values less than 75 mg/
dL (top table) and within 20% for glucose values greater than 75 mg/dL (bottom table).
Note: When glucose meter results are compared to the laboratory results, difference values below 75mg/dL are expressed in mg/dL, while
those above 75 mg/dL are compared in percent.
IMPORTANT INFORMATION ABOUT ALTERNATE SITE TESTING (AST)
Sites other than your fingertip may have fewer nerve endings, so obtaining a blood sample from these sites
may be less painful. The technique for alternate site testing is different from fingertip testing. Blood glucose
results from sites other than your fingertip could be significantly different due to blood glucose levels changing
rapidly after a meal, insulin, or exercise.
Consult your Diabetes Healthcare Professional prior to testing from a site other than your fingertips. Only palm
AST is recommended. Other sites should not be used.
Results obtained from sites other than the fingertip may differ significantly as is the case with all blood glucose
monitoring systems. Rapidly changing results are likely to occur after eating. Insulin dosing and physical
activity are shown in the fingertip more quickly than in alternate sites.
Consider alternate site testing when:
• Testing before a meal.
• You are in a fasting state.
• Two hours have passed since a meal.
• Two hours have passed since insulin dosing.
• Two hours have passed since physical activity.
Ask your Diabetes Healthcare Professional about recommended testing procedures when operating machinery
or driving a car, as fingertip testing is usually the preferred method of testing under these circ*mstances.
If bruising occurs, you may choose to lance a fingertip instead.
U.S. Patent 6,916,410 B2 is licensed by ARKRAY, Inc.
Distributed by:
Walmart Inc.,
Bentonville, AR 72716
855.776.0662
ReliOnBGM.com
Made in Korea or Taiwan
the system until the control solution result is within the acceptable range. If you
1.5-1.9 U
30-35 µg
6-8 µg
n
SD (mg/dL)
100
1.28
100
2.43
100
4.10
100
5.65
100
8.24
Professional User
The ReliOn™ Prime Blood Glucose Monitoring
1.1
System was tested on 119 participants in
duplicate (238 values), and the results were
-14.4
compared to the laboratory results. The
0.99
tables below show how well the two methods
119 (238 results)
compared.
47-522 mg/dL
Within
± 5 mg/dL
± 10 mg/dL
N = 8/12
67%
Within
± 5 %
N = 104/226
N = 170/226
46%
Use fingertip testing:
• Within two hours after a meal.
• Within two hours after insulin dosing.
• Within two hours after physical activity.
• If you have a history of hypoglycemia, are experiencing low
blood sugar, or suffer from hypoglycemic unawareness
(you cannot tell when you have low blood glucose).
• To confirm your blood glucose level if your AST
result is not consistent with how you feel.
• During times of stress or illness
100%
(12/12)
99%
(224/226)
238 results:
(119 participants)
Palm
100%
(18/18)
97%
(212/218)
236 results
(118 participants)
CV%
2.90
2.70
2.84
2.87
2.51
Within
Within
Within
± 15 mg/dL
± 20 mg/dL
N = 12/12
N = 12/12
N = 12/12
100%
100%
100%
Within
Within
Within
± 10 %
± 15 %
± 20%
N = 209/226
N = 224/226
75%
92%
99%
P/N 1944-06 Rev 12/20
