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510(k) Data Aggregation
K Number
K014167Device Name
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Date Cleared
2002-02-19
(62 days)
Product Code
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
POLYMEDICA PHARMACEUTICALS, U.S.A., INC.]
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Liberty™ Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use in the home by persons with diabetes as an aid to monitor the effectiveness of diabetes control.
Device Description
The Liberty™ Blood Glucose Monitoring System consists of the following elements: test strips; a battery operated, portable, compact meter; and a control solution.
Instrument Operating Principle: photometric
Reagent Test Principle: glucose oxydase
The Liberty™ System is based on photometric biosensor technology. The test strip is first inserted into the meter and the meter is switched on by pressing the "ON" button. A code number will appear on the display that should match the code on the vial of strips. An icon showing a flashing drop near the end of a test strip will appear on the display to prompt the user to apply a drop of blood. When a drop of blood is applied to the top of the strip at the mesh-filled target area, it flows into the membrane and starts the measurement. This is indicated on the display by a moving bar. After approximately 30 seconds, a glucose reading is displayed on the meter. The reading is stored in the meter memory with a date and time.
The Liberty™ System uses a photometric test strip that includes glucose oxidase to generate a color reaction that is proportional to the concentration of glucose in the sample.
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