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510(k) Data Aggregation
K Number
K070239Device Name
MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Date Cleared
2007-05-25
(120 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EXIR PHARMACEUTICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Maximed Exichek TD 4224 Blood glucose monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the Maximed Exichek TD 4224 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.
Device Description
Maximed Exichek TD 4224 blood glucose monitoring system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
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