Search Results

The Bioland 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 Bioland 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 as an aid to monitor the effectiveness of diabetes control. The Bioland Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland Blood Glucose Monitoring System is not for use in neonates.

Device Description

The Bioland Blood Glucose Monitoring System (hereafter as the System) is an in vitro diagnostic device intended for the measurement of glucose in capillary blood. The System consists of the Bioland Blood Glucose Meter, Bioland Blood Glucose Test Strips, lancing device / sterile lancet and Bioland Glucose Control Solution. The Bioland Glucose Control Solution is for use with the Bioland Blood Glucose Meter and Bioland Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. These products have been designed and tested to work together as a system to produce accurate blood glucose test results. The measured result can be transferred to the appointed equipment that has been connected via the Bluetooth function.

AI/ML Overview

The Bioland Blood Glucose Monitoring System is a device intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. It is for self-testing by people with diabetes at home.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on the FDA Guideline "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016, and relevant CLSI and ISO standards. The studies evaluate various performance aspects of the system.

Study/Test	Acceptance Criteria	Reported Device Performance and Compliance
Altitude Study	Individual bias < ±10% compared with the mean value of Glucose Analyzer YSI 2300. SD < 5.0 mg/dL for glucose < 100 mg/dL, and CV < 5.0% for glucose ≥ 100 mg/dL.	Individual bias < ±10%. SD < 5.0 mg/dL for glucose < 100 mg/dL. CV < 5.0% for glucose ≥ 100 mg/dL. Meets acceptance criteria. No significant altitude effects from 298 feet (91 m) to 10,744 feet (3,275 m).
Detection Limit Evaluation	Display "Lo" when sample glucose < 20 mg/dL. Display "Hi" when sample glucose > 600 mg/dL.	Displays "Lo" for glucose < 20 mg/dL. Displays "Hi" for glucose > 600 mg/dL. Meets acceptance criteria.
Hematocrit Interference Study	Mean differences < ±10 mg/dL at glucose < 100 mg/dL. Mean differences < ±10% at glucose ≥ 100 mg/dL. All SD and CV within 5.0 mg/dL and 5.0% respectively.	Mean differences within ±10 mg/dL (glucose < 100 mg/dL) and within ±10% (glucose ≥ 100 mg/dL) for Hct 20% to 60%. All SD and CV within 5.0 mg/dL and 5.0%. Meets acceptance criteria. Hct range from 20% to 60% is available.
Interference Substances Evaluation	No significant interference from specific endogenous and exogenous substances at tested concentrations. The % difference between test and control samples should be within acceptable limits.	Highest concentration tested at which no significant interference was observed for 24 substances (e.g., Acetaminophen ≤ 8.0 mg/dL, Ascorbic Acid ≤ 5.0 mg/dL, Bilirubin ≤ 90 mg/dL, etc.). Implies adherence to acceptance criteria for the tested substances.
Linearity Evaluation	Correlation coefficient (r) > 0.95. 100% of individual glucose results bias fall within ±10% or ±10 mg/dL (comparison to a reference method like YSI 2300).	Correlation coefficient r = 0.9998 (device G-427B and YSI 2300 highly correlated). 100% of individual bias within ±10% or ±10 mg/dL. Meets acceptance criteria. Linearity acceptable between 40 to 600 mg/dL.
Precision Testing	CV within 5% at glucose concentration ≥ 100 mg/dL. SD within 5 mg/dL at glucose concentration < 100 mg/dL for both within-run and within-day precision.	Within-run: Pooled CV for 3 lots: 6.5% (30-50 mg/dL), 3.5% (51-110 mg/dL), 3.6% (111-150 mg/dL), 3.4% (151-250 mg/dL), 3.3% (251-400 mg/dL). Pooled SD: 2.6 (30-50 mg/dL). Within-day: Pooled CV for 3 lots: 5.0% (30-50 mg/dL), 2.9% (51-110 mg/dL), 3.6% (111-150 mg/dL), 2.3% (151-250 mg/dL), 2.0% (251-400 mg/dL). Pooled SD: 2.0 (30-50 mg/dL). Meets acceptance criteria.
Robustness Validation Test	Appearance and structures of meters normal after cleaning/disinfection. Individual bias for accuracy tests < ±10 mg/dL for glucose < 75 mg/dL and < ±10% for glucose > 75 mg/dL.	Meters normal after 3,650 cycles of cleaning/disinfection. Individual bias < ±10 mg/dL (glucose < 75 mg/dL) and < ±10% (glucose > 75 mg/dL). Meets acceptance criteria.
Short Volume Detection Testing	Device detects insufficient blood volume and does not start measurement.	Device detects insufficient blood volume (blood volume < 0.7uL) and the 5-second countdown does not start. Meets acceptance criteria. Required sample volume ≥ 0.7uL.
System Operation Conditions Testing	Bias or bias % < 10 mg/dL or 10%. CV/SD < 5.0% / 5.0 mg/dL.	Bias or bias % < 10 mg/dL or 10%. CV/SD < 5.0% / 5.0 mg/dL. Meets acceptance criteria. Operating conditions: 50°F-104°F (10°C-40°C), 15%-85% RH.
Equipment Temperature Exposure Limits (Storage)	Function and repeatability of meters after exposure to extreme temperatures (-4°F to 131°F) fall within acceptance criteria.	Meters function and repeatability meet acceptance criteria after exposure to -4°F and 131°F. Meets EN ISO 15197:2015 requirements.
Equipment Humidity Exposure Limits (Storage)	Function and repeatability of meters after exposure to extreme humidity (93±3% RH at 89.6°F) fall within acceptance criteria.	Meters function and repeatability meet acceptance criteria after exposure to 93±3% RH at 89.6°F. Meets EN ISO 15197:2015 requirements.
Vibration and Shock Test	Function and repeatability after vibration and drop tests fall within acceptance criteria.	Meters function and repeatability meet acceptance criteria after vibration and drop tests. Meets IEC 60068-2-64:2008, IEC 61010-1:2010, and EN ISO 15197:2015 requirements.
Shelf Life Evaluation	Specific stability periods for unopened and in-use vials of test strips and control solutions.	Unopened test strips stable for 24 months, in-use (opened) for 90 days. Unopened control solutions stable for 12 months, in-use (opened) for 90 days. Meets ISO 23640:2011 guidelines.
Sample Perturbation Study	Sampling perturbation has no significant effect on precise blood glucose measurement.	Results show no significant effect on precise blood glucose measurement from sampling perturbation.
Testing with Used Strips	System does not provide measurement data and countdown does not activate when a used test strip is inserted.	System does not provide measurement data and 5-second countdown does not activate when a used test strip is inserted.
User Performance Study (Lay User Study)	Over 95% of individual bias ±15% for glucose concentration across the entire range. Lay users can operate the system properly.	98.58% (346/351) of individual bias within ±15% for glucose concentration across the entire range. 100% (351/351) within ±20%. Lay users can operate the system properly after reading the user manual, even without guidance.
Satisfaction Evaluation	More than 85% of volunteers agree that labels and user manual provide enough information. More than 95% of volunteers' score higher than 80 points (for understanding materials).	More than 85% agree labels/manual provide enough info. More than 95% scored >80 points. Indicates written materials provide sufficient understandable information for lay users.
Usability Engineering File	No usability problems when validated under normal and worst-case scenarios.	Evidence shows no usability problem when validated under normal conditions and worst-case scenarios.
Virucidal Efficacy (Disinfection)	Pass acceptance criteria for HBsAg efficacy on main housing materials (ABS), test slot (PMMA), and LCD display lens (PC).	Results passed acceptance criteria for all three parts of the subject device (ABS, PMMA, PC) using Clorox Germicidal Wipes.

2. Sample Sizes Used for the Test Set and Data Provenance

The document details sample sizes for various tests:

User Performance Study (Lay User Study): The test set included 351 individual glucose measurements.
Precision Testing (Within-run and Within-day): Tables provided show data for 3 lots of test strips, with measurements across 5 glucose concentration intervals. Although exact number of samples for each interval isn't explicitly stated, these tables typically involve multiple replicates (e.g., 10-20 replicates per lot per glucose concentration level). For example, it lists means, SDs, and CVs implying multiple measurements were taken.
Other tests (Altitude, Hematocrit, Linearity, Interference, etc.): The specific number of individual samples for these tests is generally not explicitly quantified in the provided summary. However, these are standard laboratory tests that involve a sufficient number of replicates and samples at various concentrations to ensure statistical validity, following guidelines such as CLSI EP7-A2, CLSI EP6-A, and FDA guidelines.
Data Provenance: The document does not explicitly state the country of origin of the data for these studies or whether they were retrospective or prospective. Given that Bioland Technology Ltd. is located in Shenzhen, Guangdong, People's Republic of China, it is highly probable that the studies were conducted in China. The studies are described as "Pre-clinical data" and "Summary of performance testing," suggesting they were specifically conducted prospectively for this 510(k) submission to demonstrate device performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the number of experts or their specific qualifications for establishing ground truth. Instead, it relies on a reference method, the Glucose Analyzer YSI 2300, which is a widely accepted and highly accurate laboratory instrument for determining blood glucose concentration. This method inherently serves as the "ground truth" comparator for the device's measurements.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned in the context of human expert review of results, as the studies primarily rely on direct comparison to a laboratory reference standard (YSI 2300) and quantitative statistical analysis. For the user performance study, the acceptance criteria are numerical (e.g., % of results within a certain bias), not subjective expert judgment that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted. This device is a self-monitoring blood glucose system, not an imaging AI system where human readers assist or benefit from AI. The user performance study evaluates the lay user's ability to operate the device correctly and obtain accurate results, which is a different type of assessment than an MRMC study.

6. Standalone Performance (Algorithm Only)

The device itself (Bioland Blood Glucose Monitoring System) is an "algorithm only" or "standalone" device in the sense that it provides a direct glucose measurement without human interpretation beyond reading the displayed number. The performance tests described (Precision, Linearity, Hematocrit, etc.) directly assess this standalone performance against a proven reference method (YSI 2300). The user performance study then adds the human-in-the-loop component, evaluating the system's performance when operated by lay users.

7. Type of Ground Truth Used

The primary ground truth used for the performance studies (e.g., Altitude, Hematocrit, Linearity, Precision) is comparison to a laboratory reference method, specifically the Glucose Analyzer YSI 2300. This is a highly accurate and precise instrument that measures glucose in blood samples. For the user performance study, the "ground truth" for the glucose values themselves would also be obtained from such a reference method, against which the lay user's device readings are compared.

8. Sample Size for the Training Set

This document describes a premarket notification (510(k)) for a medical device that measures blood glucose. It is not an AI/ML device that requires a "training set" in the sense of machine learning. The device's underlying "algorithm" is the electrochemical biosensor technology. Therefore, the concept of a "training set" for an algorithm, as seen in AI/ML, does not apply here. The data presented are from verification and validation studies for a traditional in vitro diagnostic device.

9. How the Ground Truth for the Training Set Was Established

As stated in point 8, the concept of a training set is not applicable to this type of device. The ground truth for the test and validation of the device's performance was established using a Glucose Analyzer YSI 2300 as the reference method.

Ask a Question

Ask a specific question about this device

Page 1 of 1