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OneTouch Normal Control Solution - 2 Vials*******MFG DISCONTINUED 2/13/14
Product ID: 800064
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Product Summary
  • Blue Control Solution
  • For use with OneTouch Basic Test Strips
  • Sufficient volume for 75 tests per vial
  • Used as a quality control check to verify the accuracy of your blood glucose test results

Intended Use

For use with ONE TOUCH® Brand Meters and Genuine ONE TOUCH® Test Strips as a quality control check to verify the accuracy of your blood glucose test results.

Not for use with OneTouch Ultra systems.


Summary and Explanation

ONE TOUCH® Normal Control Solution is a blue solution containing a measured amount of glucose which reacts with a ONE TOUCH Reagent Test Strip. When used according to the same procedure as whole blood, the control solution should give results within the expected range printed on the test strip package. Obtaining a single result within the expected range is sufficient to verify system performance. Control solution should be used at least once a week, whenever you suspect the meter or test strips may not be functioning properly, and every time a new package of test strips is opened. Use of control solution is also recommended for teaching or learning the system. For teaching/learning purposes, three consecutive results within the expected range should be obtained to verify that the correct procedure is being followed to provide accurate results.


Chemical Composition

The ONE TOUCH Normal Control Solution is an aqueous solution which contains D-glucose as the reactive ingredient in the approximate concentration of 0.1%. The inert ingredients and preservatives are listed below in approximate concentrations:

- Polyvinylacetate (aqueous emulsion).............14.0%

- Fumed silica.........................................................0.1%

- Sodium benzoate.................................................0.2%

- Disodium EDTA ...................................................0.1%

- Copper phthalocyanine-tetrasulfonic acid

- tetrasodium salt (blue dye) ............................0.0075%

- Antifoaming agent ...............................................0.02%

ONE TOUCH Normal Control Solution is formulated to react in theONE TOUCH System as would a fresh whole blood sample containin glucose at a concentration of approximately 100 mg/dL (5.6 mmol/L). However, the reaction rate of glucose in an aqueous medium is different from glucose in whole blood, and the color of the control solution is different from that of whole blood; therefore, the actual empirical concentration of the analyte in the control solution is different from the target value of the control. This difference should be taken into consideration when evaluating the ONE TOUCH Normal Control Solution with other methods.


Precautions

- ONE TOUCH Normal Control Solution is not intended for human consumption.

- ONE TOUCH Normal Control Solution is for in vitro diagnostic use only.

- Shake the control solution well before using.


Storage and Handling

ONE TOUCH Normal Control Solution must be shaken well to resuspend polymers before use. No reconstitution or dilution is necessary. Store the control solution at room temperatures below 86F (30C). Do not refrigerate. Use before the expiration date shown on the vial. Wipe the tube tip and reseal tightly after each use. If the tip clogs, tap the tip slightly on a clean, hard surface, shake again, and then use. IMPORTANT: Discard any unused portion 90 days after opening. Note the discard date on the control solution vial label.


Procedure

Materials provided:

-ONE TOUCH®Normal Control Solution (sufficient quantity for 75determinations per vial)

Materials required but not provided:

-A ONE TOUCH®Brand Meter and accompanying owner’s booklet

-Genuine ONE TOUCH®Test Strips


Test Procedure:

To perform a control solution test, follow the same test procedure as for a whole blood glucose test, substituting control solution for the drop of blood. Refer to your Meter Owner’s Booklet for further test instructions.


Technical Pointers:

Accurate results depend upon you carefully following all product use instructions. Follow these technical pointers whenever you test with ONE TOUCH Normal Control Solution:

1. Shake control solution well before using.

2. If large bubbles are present at the tip of the vial, wipe the bubbles off with a clean tissue before applying the drop of control solution to the test spot.

3. Apply the entire drop of control solution onto the test spot at once. Avoid wiping or smearing the control solution onto the test spot. To avoid contaminating the control solution with enzyme, DO NOT TOUCH THE TEST SPOT WITH THE TIP OF THE VIAL.

4. Apply the drop of control solution to the middle of the test spot and cover the spot completely.


Expected Results

At room temperature, ONE TOUCH Normal Control Solution should yield results that 95% of the time fall within the expected range printed on the test strip package. Valid results also depend upon the meter being properly coded to match the code printed on each test strip package. If test results fall outside the expected range, the test should be repeated. Results which fall outside the expected range may indicate procedural error, control solution expiration or contamination, test strip deterioration, meter malfunction, or extremes in testing temperature. Refer to the Meter Owner’s Booklet for troubleshooting assistance. If you are unable to resolve the problem, contact the Technical Service Department at LifeScan.


I M P O R T A N T :

If your control solution results fall outside of the expected range, the system is not functioning properly. DO NOT use the system to test your blood glucose until you get a control solution reading that falls within the expected range.

Questions?

If you have any questions about this product, please call LifeScan toll-free at 1-800-227-8862.

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