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510(k) Data Aggregation
K Number
K212248Device Name
GlucoLeader Enhance 2 Blood Glucose Monitoring System
Manufacturer
Date Cleared
2022-08-29
(406 days)
Product Code
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HMD BioMedical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GlucoLeader Enhance 2 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 fingertip. The GlucoLeader Enhance 2 Blood Glucose Monitoring System is comprised of the GlucoLeader Enhance 2 Blood Glucose Meter and the GlucoLeader Enhance 2 Blood Glucose Test Strips. The GlucoLeader Enhance 2 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home (over the counter [OTC]) as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance 2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance 2 Blood Glucose Monitoring System is not for use in neonates.
Device Description
The GlucoLeader Enhance 2 Blood Glucose Monitoring System is designed to pursuit the accuracy in blood glucose monitoring to provide with testing. The GlucoLeader Enhance 2 Blood Glucose Monitoring System mainly consists of four parts as below,
- (1) GlucoLeader Enhance 2 Blood Glucose Meter
- GlucoLeader Enhance 2 Blood Glucose Test Strips* (2)
- Glucose Control Solutions (L1, L2)* (3)
- (4) Check Strip*.
- * These products are intended to be used together to get accurate blood glucose test results. They are not included in the kit package, and should be purchased separately.
Display screen size of the meter is 1.73" x 1.7", and weight of the meter is 0.122 lbs (55.2 grams). The GlucoLeader Enhance 2 Blood Glucose Monitoring System is traceable to the NIST (SRM) 917A. The GlucoLeader Enhance Glucose Control Solutions have L1 and L2 levels for optional purchasing.
The GlucoLeader Enhance 2 Blood Glucose Test Strips have been updated with Glucose dehydrogenase-FAD Enzyme, which not only improves the accuracy of measurements, but also increases the HCT interference range up to 10-70%. Also, the required test blood sample volume is reduced to 0.8 µL, and the test reaction time is only 5 seconds.
If the GlucoLeader Enhance 2 Blood Glucose Meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be disinfected prior to use by the second person. Consult your healthcare professional if unusual readings occur.
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K Number
K182428Device Name
GlucoLeader Enhance Blood Glucose Monitoring System
Manufacturer
Date Cleared
2019-05-08
(244 days)
Product Code
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HMD BioMedical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GlucoLeader Enhance Blood Glucose Monitoring System is comprised of GlucoLeader Enhance Blood Glucose Meter and GlucoLeader Enhance Blood Glucose Test Strips.
The GlucoLeader Enhance 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 fingertip. The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance Blood Glucose Monitoring System is not for use in neonates.
Device Description
The GlucoLeader Enhance Blood Glucose Monitoring System is designed to pursuit the accuracy in blood glucose monitoring to provide you with easy and comfortable testing. The GlucoLeader Enhance Blood Glucose Monitoring System mainly consists of four parts as below,
1) GlucoLeader Enhance Blood Glucose Meter
2) GlucoLeader Enhance Blood Glucose Test Strips*
3) GlucoLeader Enhance Glucose Control Solutions (L1-Low glucose level, L2-High glucose level)*
4) GlucoLeader Enhance Check Strip*.
*These products are intended to be used together to get accurate blood glucose test results. They are not included in the kit package, and should be purchased separately.
The meter display screen size of 1.73" x 1.7" is large and easy-to-read, and the meter weight of 0.122 lbs. (55.2 grams) is lightweight and portable for your convenience. The GlucoLeader Enhance Blood Glucose Monitoring System is traceable to the NIST (SRM) 917A. The GlucoLeader Enhance Glucose Control Solutions have L1 and L2 levels for optional purchasing, and L1 is low glucose level and L2 is high glucose level.
The GlucoLeader Enhance Blood Glucose Meter has the latest technology for blood glucose monitoring and is made with quality components. The GlucoLeader Enhance Blood Glucose Test Strips have been updated with Glucose dehydrogenase-FAD Enzyme, which not only improves the accuracy of measurements, but also increases the HCT interference range up to 10-70%. Also, the required test blood sample volume is reduced to 0.8 µL, and the test reaction time is only 5 seconds.
If your GlucoLeader Enhance Blood Glucose Meter is being operated by a second person who is providing testing assistance to the user. the meter and lancing device should be disinfected prior to use by the second person. Consult your healthcare professional if unusual readings occur.
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Ask a specific question about this device
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