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510(k) Data Aggregation
(406 days)
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.
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*.
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- 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.
The provided document is a 510(k) summary for the "GlucoLeader Enhance 2 Blood Glucose Monitoring System". It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study results for the device's performance.
Specifically, it states: "No new clinical test data was used to support the decision of substantial equivalence." This means that the document does not contain the information requested regarding acceptance criteria and performance studies for the GlucoLeader Enhance 2 Blood Glucose Monitoring System itself. The changes in this new model (color, BLE module) were deemed not to affect the accuracy and effectiveness, thus relying on the predicate device's established performance.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions about sample sizes, data provenance, expert involvement, ground truth establishment, or MRMC studies for this specific device.
If the information about acceptance criteria and performance studies for the predicate device (GlucoLeader Enhance Blood Glucose Monitoring System, K182448) were available, I would be able to answer some of these questions.
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(244 days)
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.
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,
-
GlucoLeader Enhance Blood Glucose Meter
-
GlucoLeader Enhance Blood Glucose Test Strips*
-
GlucoLeader Enhance Glucose Control Solutions (L1-Low glucose level, L2-High glucose level)*
-
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.
The GlucocLeader Enhance Blood Glucose Monitoring System is a medical device for quantitative measurement of glucose in fresh capillary whole blood samples. It is intended for self-testing by people with diabetes at home.
Here's an analysis of its acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (User Performance) | "The GlucoLeader Enhance blood glucose meter gave results within 15% of their true blood glucose level 351 out of 360 times." (This implies a requirement for at least 97.5% of readings to be within ±15%.) | Within ±5%: 59.7% (215/360) Within ±10%: 84.7% (305/360) Within ±15%: 97.5% (351/360) Within ±20%: 100% (360/360) |
| **System Accuracy at Extreme Glucose Values ( 250 mg/dL, which represents a high glucose extreme, not necessarily the entire range ≥ 75 mg/dL, but confirms performance at high values.) | ||
| Within-Run Precision | CV within 5% at glucose concentration ≥ 100 mg/dL, and SD within 5 mg/dL at glucose concentration |
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