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510(k) Data Aggregation
K Number
K132663Device Name
I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Date Cleared
2015-04-20
(602 days)
Product Code
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE INTERNATIONAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The i-QARE DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The i-QARE DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The i-QARE DS-W Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The i-QARE DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The i-QARE DS-W Draw-in Blood Glucose Test Strips are for use with the i-QARE DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
Device Description
Based on an electrochemical biosensor technology and the principle of capillary action, i-QARE DS-W Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds.
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K Number
K082965Device Name
DS-A BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Date Cleared
2009-12-07
(430 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE INTERNATIONAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.
The DS-A Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. DS-A Test Strips must be used with the A-CHECK DS-A Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). Thev 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. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.
The Alliance Blood Glucose 3 levels Control Solution are for use with the A-CHECK DS-A Blood Glucose Monitoring System and DS-A Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Device Description
Based on an electrochemical biosensor technology and the principle of capillary action, DS-A Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and is displayed in 6 seconds.
The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of blood glucose in fingertip capillary whole blood. When the blood is applied to the edge of reaction zone, the blood is drawn into the reaction chamber and will display a reading on the meter. Only a small amount of blood is needed. The test strip for the quantitative measurement of blood glucose in the range is from 20-600 mg/dL (1.1-33.3 mmol/L).
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