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510(k) Data Aggregation
(307 days)
The iGlucose 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. The iGlucose Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The iGlucose 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 iGlucose Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
The iGlucose Blood Glucose Test Strips are for use with the iGlucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The iGlucose Blood Glucose Monitoring System consists of the iGlucose meter, the iGlucose test strips and the Rightest Glucose Control Solutions (GC550 level 2 and 4 (previously cleared under K092052). Bionime is seeking FDA's clearance to market and commercially distribute in the United States the iGlucose Meter and its corresponding iGlucose Test Strips.
The iGlucose meter is an electronic device that utilizes electrical characteristics technology. When used with its corresponding iGlucose Test Strips, it quantitatively measures glucose in a small drop of fresh capillary whole blood (minimum 0.75 µL). The blood drop is placed on the test strip where it interacts with reagents in the presence of glucose oxidase to produce an electrical current proportional to the amount of glucose in the sample. The oxidase electrochemical sensor of the meter measures the current and using meter software converts it to the corresponding glucose concentration. The glucose result is then displayed on the meter within 5 seconds.
Other system components include:
- Rightest lancing device labeled for "Single Patient Use only" as well as its . disposable sterile lancets.
- Meter charger and cable
- A clear cap for the lancing device
Here's a breakdown of the acceptance criteria and study information for the iGlucose Blood Glucose Monitoring System, extracted from the provided FDA 510(k) summary:
iGlucose Blood Glucose Monitoring System: Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The document states that the iGlucose meter's performance falls within acceptance criteria, and specific metrics are provided from a lay-user trial comparing the iGlucose to a reference method (YSI 2300 Plus).
| Glucose Concentration Range | Acceptance Criteria (relative to YSI) | Reported Device Performance |
|---|---|---|
| < 75 mg/dL | Not explicitly stated in table, but performance is compared against ranges. | Within ±5 mg/dL: 33.3% (2/6) Within ±10 mg/dL: 83.3% (5/6) Within ±15 mg/dL: 100.0% (6/6) |
| ≥ 75 mg/dL | Not explicitly stated in table, but performance is compared against ranges. | Within ±5%: 43.5% (64/147) Within ±10%: 81.6% (120/147) Within ±15%: 95.2% (140/147) |
| Measuring Range (Linearity) | 20-600 mg/dL | Linear regression analysis resulted in a mean slope ranging from 0.9808 to 0.9952 and an R^2^ value of 0.9996 to 0.9997, supporting linearity between 20 and 600 mg/dL. |
| Precision (Repeatability) | Not explicitly stated in table, but implied to be equivalent to predicate. | Mean mg/dL (SD, CV%) 44.4 (1.6, 3.6%) 97.6 (2.0, 2.1%) 132.5 (2.3, 1.8%) 213.2 (3.5, 1.6%) 364.0 (5.4, 1.5%) (Falls within acceptance criteria and equivalent to predicate device) |
| Precision (Intermediate) | Not explicitly stated in table, but implied to be equivalent to predicate. | Mean mg/dL (SD, CV%) 42.7 (1.2, 2.8%) 96.7 (2.0, 2.0%) 274.3 (4.6, 1.7%) (Falls within acceptance criteria and equivalent to predicate device) |
| Hematocrit Range | 20-60% | Measurements were within acceptance criteria for the entire HCT range of 20-60%. |
| Minimum Sample Volume | 0.75 µL | Error message displayed if sample < 0.70µL. At sample volumes ≥ 0.75µL, all test results were within ±10% compared to reference measurements. |
| Operating Temperature | 10-40°C (50-104°F) | Results met acceptance criteria and support this range. |
| Operating Humidity | 10-90% RH | Results met acceptance criteria and support this range. |
| Altitude | Up to 10,000 ft | Results met acceptance criteria and support this claim. |
2. Sample Sizes and Data Provenance
-
Test Set (Lay-User Trial):
- Sample Size: 153 subjects.
- Data Provenance: Conducted in a US clinic (prospective, clinical trial). ClinicalTrials.gov Identifier: NCT02709707.
-
Bench Studies (Precision, Linearity, Interferences, Hematocrit, Sample Volume, Temperature/Humidity, Altitude): Specific sample numbers are provided for each of these studies (e.g., 300 tests for each glucose level in repeatability, venous blood samples spiked to 15 levels for linearity, 19 substances at 2 glucose concentrations for interferences). The data provenance for bench studies is not explicitly stated as country of origin but implies laboratory testing.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
Not applicable for this type of device and study. The ground truth for the lay-user trial and other performance studies was established using a reference laboratory instrument, not human experts.
4. Adjudication Method for the Test Set
Not applicable. The lay-user trial involved direct comparison of iGlucose readings to a reference laboratory method (YSI 2300 Plus).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (e.g., imaging devices) where human readers interpret results, and the AI's impact on their performance is being evaluated. This device (blood glucose monitoring system) is an objective quantitative measurement device.
6. Standalone Performance Study
Yes, standalone performance studies were extensively conducted. The summary describes "Bench studies including evaluation of analytical performance as well as clinical performance studies" where the iGlucose meter's readings were compared directly against the reference method (YSI 2300 Plus). The lay-user trial also evaluates the device's standalone performance in the hands of lay-users.
7. Type of Ground Truth Used (Test Set)
Reference Method: The ground truth for the performance evaluations (precision, linearity, interferences, hematocrit, sample volume, temperature/humidity, altitude, and lay-user trial) was established by comparing the iGlucose meter's results to those obtained from the Yellow Springs Instrument YSI 2300 Plus analyzer. This is a recognized laboratory reference method for glucose measurement.
8. Sample Size for the Training Set
The document does not specify a separate "training set" in the context of machine learning. This is a traditional medical device (electro-chemical sensor) where performance is characterized through bench and clinical testing against a reference standard, rather than a machine learning model that requires a distinct training phase.
9. How Ground Truth for the Training Set Was Established
As mentioned above, a separate "training set" as understood in machine learning is not applicable here. The performance of the device (both subject and predicate) is based on established electrochemical principles, and its accuracy is validated through comparison to the YSI 2300 Plus reference analyzer across various conditions and samples.
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(379 days)
The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM700 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 Rightest Blood Glucose Monitoring System GM700 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Rightest Blood Glucose Test Strip GS700 is for use with the Rightest Blood Glucose meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.
The Rightest Control Solution GC700 is for use with the Rightest Blood Glucose meter GM700 and Rightest Blood Glucose Test Strips GS700 to check that the meters and test strip are working together properly and that the test is performing correctly.
Our Rightest Blood Glucose Monitoring System GM700 consists of the following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strips GS700, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The Rightest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.
A Rightest Blood Glucose Monitoring System GM700 kit box may contain different bundled items.
Here's a summary of the acceptance criteria and study information for the Rightest Blood Glucose Monitoring System GM700, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only explicitly states that the device "met the acceptance criteria" for the system accuracy study. It does not numerically list the specific acceptance criteria for blood glucose monitoring systems, nor does it provide a direct numerical performance result. In the absence of a detailed table from the source, I will indicate the general finding.
| Metric (Implied) | Acceptance Criteria (Not explicitly stated in text but generally understood for BGMS) | Reported Device Performance |
|---|---|---|
| System Accuracy | (General criteria for blood glucose monitoring systems, not provided in this text) | Met the acceptance criteria |
| User Performance | (Criteria for lay user accuracy, not provided in this text) | Lay consumers could obtain accurate results |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Accuracy Study: 103 patients
- Sample Size for User Performance Study: Not explicitly stated, but implies a sufficient number of lay consumers participated.
- Data Provenance: Not explicitly stated, but the submission is from a Taiwanese company (BIONIME CORPORATION NO 694, RENHUA ROAD, DALI DIST., TAICHUNG CITY, TAIWAN 412), suggesting the studies may have been conducted in Taiwan or a related region. It does not specify if the data was retrospective or prospective, but clinical studies are generally prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The ground truth for the accuracy study was established by "plasma glucose values on a lab instrument," implying trained laboratory personnel were involved, but their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- The text does not mention an adjudication method (such as 2+1 or 3+1) for establishing the ground truth. The ground truth was based on a "lab instrument" for plasma glucose values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the performance of a medical device (blood glucose monitor), not an AI algorithm assisting human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- This question is not applicable as the device is a Blood Glucose Monitoring System, which includes the meter, test strips, and control solution, and is used by a human. The "standalone" concept typically applies to AI algorithms. The system itself is the "standalone" diagnostic tool.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the system accuracy study was established using "plasma glucose values on a lab instrument." This is a reference measurement, often considered a highly accurate and standardized method for glucose determination.
8. The Sample Size for the Training Set
- Blood Glucose Monitoring Systems are typically developed through electrochemical and hardware engineering, and thus do not involve a "training set" in the context of machine learning. Therefore, a sample size for a training set is not applicable to this device.
9. How the Ground Truth for the Training Set Was Established
- As the concept of a "training set" is not applicable to the development of this device, the question of how its ground truth was established is not applicable. Device performance is validated against established laboratory reference methods and clinical accuracy standards, rather than "training" an algorithm.
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