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510(k) Data Aggregation
(86 days)
DiaCheck Smart Blood Glucose Monitoring System: The DiaCheck Smart Blood Glucose Monitoring System is intended for the quantitative rno Blacmost of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The DiaCheck Smart Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Smart Blood Glucose Test Strips: The DiaCheck Smart Blood Glucose Test Strips are for use with the DiaCheck Smart Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The Test Strip is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Glucose Control Solution: The DiaCheck Control solutions are intended for use with DiaCheck Blood Glucose The DiaCheck Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.
DiaCheck Superior Blood Glucose Monitoring System: The DiaCheck Superior Blood Glucose Monitoring System is intended for the rne Black our of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The DiaCheck Superior Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Superior Blood Glucose Test Strip: The DiaCheck Superior Blood Glucose Test Strips are for use with the DiaCheck rne Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The Test Strip is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Glucose Control Solution: The DiaCheck Control solutions are intended for use with DiaCheck Blood Glucose The DiaCheck Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.
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Please note that the provided document is a 510(k) clearance letter from the FDA, not a full study report or clinical trial documentation. Therefore, much of the detailed information typically found in such reports (like sample sizes for specific training/test sets, expert qualifications, adjudication methods, or MRMC study results) is not present. This letter primarily focuses on the FDA's determination of substantial equivalence based on the submitted materials, rather than providing a detailed breakdown of the underlying studies.
However, I can extract the acceptance criteria and the reported performance as presented in this document, and infer what can be from the context.
Acceptance Criteria and Device Performance for Glucose Test System
The DiaCheck Smart Blood Glucose Monitoring System and DiaCheck Superior Blood Glucose Monitoring System are intended for quantitative measurement of glucose in fresh capillary whole blood samples from fingertips. Based on the provided FDA 510(k) clearance, the acceptability of the device is determined by its substantial equivalence to legally marketed predicate devices, implying that its performance meets the regulatory standards for accuracy and reliability established for such systems.
The specific acceptance criteria for blood glucose monitoring systems typically involve accuracy metrics compared to a laboratory reference method. While these exact criteria are not explicitly detailed in the FDA clearance letter, common standards (e.g., ISO 15197) for blood glucose meters require that for glucose concentrations ≥ 4.2 mmol/L (75 mg/dL), 95% of the measured values should fall within ±15% of the reference value, and for glucose concentrations < 4.2 mmol/L (75 mg/dL), 95% of the measured values should fall within ±0.83 mmol/L (±15 mg/dL) of the reference value.
The document indicates that the device has met the requirements for substantial equivalence, implying its performance aligns with these or similar established standards for blood glucose monitoring.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Inferred from regulatory standards for blood glucose meters, e.g., ISO 15197) | Reported Device Performance (Inferred from FDA's substantial equivalence determination) |
|---|---|
| Accuracy relative to a reference method: | The FDA has determined the device to be substantially equivalent to legally marketed predicate devices. This implies that the DiaCheck Superior Blood Glucose Monitoring System's performance for quantitative glucose measurement in capillary whole blood meets the established accuracy and precision requirements of the predicate devices and regulatory standards. The letter itself does not provide specific performance statistics (e.g., % within ±15% of reference, mean bias, etc.) but rather acknowledges that the submitted data demonstrated this equivalence. |
| - For glucose concentrations ≥ 4.2 mmol/L (75 mg/dL): 95% of measured values within ±15% of reference. | |
| - For glucose concentrations < 4.2 mmol/L (75 mg/dL): 95% of measured values within ±0.83 mmol/L (±15 mg/dL) of reference. | |
| Precision (repeatability/intermediate precision): (Typically assessed through coefficients of variation) | (Not detailed in the provided document, but implicitly met for substantial equivalence.) |
| Interfering substances: No significant interference from common endogenous or exogenous substances. | (Not detailed in the provided document, but implicitly met for substantial equivalence.) |
| Operating range: Measurement capabilities across a specified glucose concentration range for intended use. | (Not detailed in the provided document, but implicitly met for substantial equivalence within the specified indications for use.) |
2. Sample size used for the test set and the data provenance
The provided FDA 510(k) clearance letter does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). These details would typically be found in the manufacturer's submission documentation, which is not included here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided FDA clearance letter. For glucose monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer) and does not typically involve expert consensus for individual readings.
4. Adjudication method for the test set
Not applicable, as ground truth for this type of device is established by a reference laboratory method rather than human expert consensus requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the DiaCheck Superior Blood Glucose Monitoring System is a standalone diagnostic device for quantitative bodily fluid measurement, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this device is inherently a standalone diagnostic system. Its performance evaluation would have been conducted as a standalone system (algorithm/device only) measuring glucose levels, with human involvement primarily in operating the device and collecting samples as per instructions for use. The FDA's substantial equivalence determination confirms that the device itself meets performance criteria.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For blood glucose monitoring systems, the ground truth is established using a laboratory reference method (e.g., YSI Glucose Analyzer) which is considered a highly accurate and precise method for measuring glucose concentration in blood samples.
8. The sample size for the training set
The provided FDA 510(k) clearance letter does not specify a training set size. While in vitro diagnostic devices like blood glucose meters may involve internal optimization or calibration using various samples, the concept of a "training set" in the context of typical machine learning algorithms with explicitly defined sizes is not directly applicable or typically reported in this manner for these types of devices in regulatory documents.
9. How the ground truth for the training set was established
Ground truth for any internal development, calibration, or training (if applicable) for the DiaCheck Blood Glucose Monitoring System would have been established using laboratory reference methods (e.g., YSI Glucose Analyzer) to provide accurate glucose concentration values for the samples used. This ensures the device is calibrated against a highly reliable standard.
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