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510(k) Data Aggregation
(362 days)
The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is composed of the SuperCheck Plus Multi Test Strips and SuperCheck Plus Multi Blood Glucose Meter and is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood. The Super Check Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.
The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) 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 SuperCheck Plus Multi Test Strips are for use with the SuperCheck Plus Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood.
The SuperCheck Plus Multi Control Solutions are for use with the SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) as a quality control check to verify that the meter and test strips are working together properly.
The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used by a single person and should not be shared. The SuperCheck Plus Blood Glucose Monitoring System(Model for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) 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 in not changing rapidly).
The SuperCheck Plus Test Strips are for use with the SuperCheck Plus Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or forearm.
The SuperCheck Plus Control Solutions are for use with the SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) as a quality control check to verify that the meter and test strips are working together properly.
The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) (also applicable to: SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M)) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use.
The data download functionality is optionally available and sold separately. To perform a test, when a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.
Here's an analysis of the acceptance criteria and supporting studies for the SuperCheck Plus Blood Glucose Monitoring System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for accuracy are not explicitly stated in a single consolidated table in the document, but rather described in the text, referencing ISO 15197 for precision and generally implying agreement with a reference method (YSI 2300) for overall system accuracy. The document states that the system "met the acceptance criteria" without detailing the specific criteria for system accuracy (e.g., percentage within a certain range). For precision, ISO 15197 is mentioned, which typically has performance targets based on CV (Coefficient of Variation) or absolute differences. I will infer based on the stated performance.
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| Precision | ||
| Repeatability Precision (within-run) | ||
| Glucose < 100 mg/dL: CV ≤ 7% | CV values were not more than 7% | Precision/Reproducibility |
| Glucose ≥ 100 mg/dL: CV < 5% | CV values were less than 5% | Precision/Reproducibility |
| Intermediate Precision (total precision) | ||
| Across 3 control levels: CV < 5% | CV values were less than 5% | Precision/Reproducibility |
| Linearity/Reportable Range | ||
| Correlation with reference method (r) | r = 0.9998 compared to YSI analyzer | Linearity/Assay Reportable Range |
| Measuring range | 20-600 mg/dL (Device claims this range) | Linearity/Assay Reportable Range |
| Operating Temperature | 10-40°C (50-104°F) | Study confirmed operation in this range |
| Operating Humidity | 20-80% RH (non-condensing) | Study confirmed operation in this range |
| Interfering Substances (Analytical Specificity) | ||
| Glucose < 100 mg/dL: average difference ≤ 10 mg/dL | Met this criterion for listed substances | Analytical Specificity |
| Glucose ≥ 100 mg/dL: average difference ≤ 10% | Met this criterion for listed substances | Analytical Specificity |
| Hematocrit Range | No significant effect from 20-60% | Hematocrit Study |
| Altitude | No significant effect up to 10,744 ft | Altitude Study |
| Sample Volume | ≥0.7µL produces accurate results (error message for insufficient sample volume of 0.7µL implies accuracy at or above this) | Sample Volume Study |
| Meter Reliability | All results were within the criteria after challenge (mechanical resistance, vibration, temp/humidity) | Meter Reliability Study |
| EMC and Electrical Safety | Conforms to IEC/EN 61010-1, IEC/EN 61010-2-101, IEC/EN 61326-1 and IEC/EN 61326-2-6 standards | EMC and Electrical Safety Study |
| Cleaning & Disinfection (Robustness for Meter) | No change in performance or external materials after simulated 3 years of use | Infection Control Studies |
| Disinfection Efficacy | Complete inactivation of Hepatitis B (HBV) with specified disinfectant | Infection Control Studies |
| System Accuracy (compared to YSI 2300) | "met the acceptance criteria" | System Accuracy Study |
| User Performance Study (Accuracy by Lay Users) | "met the acceptance criteria" | User Performance Study |
| User Performance Study (Ease of Use) | "easy to use for participants" | User Performance Study |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision/Reproducibility (Test Set):
- Repeatability Precision: 5 whole blood concentrations were tested. The number of replicates per concentration is not specified, but typically this involves multiple measurements (e.g., 10-20 replicates). The document doesn't specify if the samples were from a particular country. It's an in-vitro lab study.
- Intermediate Precision: 3 levels of control solutions, 3 lots of test strips, and 10 meters were tested for 10 days. This is an in-vitro lab study.
- Linearity (Test Set): 11 concentration levels of capillary whole blood samples (spiked). No specific provenance mentioned, assumed to be laboratory-prepared samples.
- Operating Temperature and Humidity Study: Not specified, assumed to be laboratory test samples.
- Analytical Specificity: Not specified, assumed to be laboratory test samples.
- Hematocrit Study: 9 hematocrit levels at 3 spiked target glucose concentrations. Not specified, assumed to be laboratory test samples.
- Altitude Study: Venous blood samples spiked to 3 glucose concentrations. Performed at 33 ft and 10,744 ft. Not specified, assumed to be laboratory test samples.
- Sample Volume Study: Blood samples spiked to 3 glucose concentrations, tested from 0.5µL to 3.0µL. Not specified, assumed to be laboratory test samples.
- System Accuracy Study (Clinical Test Set): A total of 151 subjects were recruited. The document does not specify the country of origin, but it is a "clinical" study, implying prospective participant recruitment.
- User Performance Study (Clinical Test Set): 129 participants. The document implies these were lay users who could read English, suggesting a prospective recruitment in an English-speaking country, but no specific country is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For the System Accuracy Study, the ground truth was established by a reference method, the YSI 2300 glucose analyzer. This is a highly accurate laboratory instrument, and its operation would typically be managed by trained laboratory technicians or clinical chemists. No "experts" in the sense of clinicians or radiologists are involved in establishing this type of ground truth.
- For the User Performance Study, the ground truth for comparison was also likely the YSI 2300 or another laboratory reference method, against which the lay user's results from the device were compared. The "experts" here would be the lab personnel operating the reference method.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for glucose measurements is typically established by objective laboratory reference methods (like the YSI 2300), not through expert consensus or adjudication in the way medical imaging diagnosis might be.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC) is typically done for diagnostic imaging devices where human readers interpret images, sometimes with and without AI assistance, to measure the change in diagnostic accuracy. This document describes a blood glucose monitoring system, which is a quantitative measurement device, not an imaging device. The "User Performance Study" evaluates lay users testing themselves, which is a form of human-in-the-loop performance, but it's not an MRMC study comparing AI vs. no AI assistance for diagnosis.
6. Standalone Performance
Yes, the analytical performance studies (precision, linearity, specificity, hematocrit, altitude, sample volume, meter reliability, EMC/electrical safety) are all forms of standalone performance of the device, without human-in-the-loop interpretation being the primary focus. The "System Accuracy Study" also represents the standalone analytical performance of the device when operated under controlled clinical conditions, comparing its results directly to a gold standard, without focusing on the impact of user interaction beyond the collection and application of the sample.
7. Type of Ground Truth Used
- For most analytical performance studies (precision, linearity, analytical specificity, hematocrit, altitude, system accuracy): Reference method measurements, specifically the YSI 2300 glucose analyzer.
- For meter reliability and EMC/electrical safety: Adherence to engineering specifications and relevant ISO/IEC standards.
- For infection control: Disinfection efficacy testing against a specific pathogen (HBV) and robustness testing of materials.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a blood glucose meter, which typically operates on electrochemistry principles, not an AI or machine learning algorithm that requires a training set. If there were any internal calibrations or algorithms developed during the device's design, the data used for those would be part of internal R&D and not typically disclosed as a "training set" in this type of regulatory document.
9. How the Ground Truth for the Training Set Was Established
As no training set (in the AI/ML sense) is mentioned or implied for this type of device, this question is not strictly applicable. The device's operational parameters would be based on underlying physical and chemical principles, calibrated using known glucose concentrations and validated against reference methods, rather than "trained" on a dataset with established ground truth.
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