(157 days)
The ReliOn Premier BLU Blood Glucose Monitoring System is comprised of the ReliOn Premier BLU Blood Glucose Meter and the ReliOn Premier Blood Glucose Test Strips.
The ReliOn Premier BLU Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips.
The ReliOn Premier BLU 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 system is intended to be used by a single person and should not be shared.
The system is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The ReliOn Premier BLU Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology that the meter communicates to smartphones wirelessly. The ReliOn Premier BLU BGMS has a target range indicator that upon consulting with a healthcare professional, users have the option to activate the function that displays blood glucose measurement results on a colored backlight display. By default, this indicator function is set to OFF. However, it is recommended that users consult with a healthcare professional to determine the target range for their individual needs.
This document describes the FDA's 510(k) clearance for the ReliOn Premier BLU Blood Glucose Monitoring System, comparing it to a predicate device. The information required for a comprehensive study description, such as that for an AI-based medical device, is not provided in this document. This submission focuses on engineering modifications of an existing device and its equivalence to a predicate, not on a new algorithm's performance or a comparative effectiveness study involving human readers and AI.
Therefore, many of the requested details, particularly regarding AI-specific studies (e.g., MRMC studies, standalone algorithm performance, training data details, expert consensus for ground truth on AI models), are not applicable to this submission.
However, I can extract the information relevant to the device's technical specifications and the non-clinical testing performed.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of precise quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision) or detailed reported device performance data as would be seen for a new algorithm study. Instead, it describes equivalence to a predicate device and mentions that the non-clinical tests indicated the device "performed as intended and fulfilled the specifications."
The key performance characteristics are compared to the predicate device:
| Feature | Predicate device CareSens N Premier BT (K170614) | Candidate device ReliOn Premier BLU Blood Glucose Monitoring System | Performance (as stated) |
|---|---|---|---|
| Measurement range | 20-600 mg/dL | Same | Same |
| Sample size | Minimum 0.5 µL | Same | Same |
| Test time | 5 seconds | Same | Same |
| Sample type | Fresh capillary whole blood | Same | Same |
| Calibration | Plasma-equivalent | Same | Same |
| Battery life | 1,000 tests | Same | Same |
| Power | Two 3.0V lithium batteries (disposable, type CR2032) | Same | Same |
| Memory | 1,000 test results | Same | Same |
| Target range indicator | N/A | Red, Green, Blue colored screens for below, within, and above target range. | New feature added; functionality verified. |
Acceptance Criteria (Implied from the document):
The acceptance criteria are implicitly that the ReliOn Premier BLU Blood Glucose Monitoring System demonstrates "substantial equivalence" to the predicate device, CareSens N Premier BT Blood Glucose Monitoring System (K170614), and that the modifications (target range function, LCD, PCB, labeling) perform as intended and fulfill specifications. Specific quantitative criteria for accuracy, precision, or other performance metrics (e.g., ISO standards for blood glucose meters) are not detailed in this summary.
Reported Device Performance:
"The results of these tests indicated that the ReliOn Premier BLU Blood Glucose Monitoring System, with the proposed changes outlined in this document, performed as intended and fulfilled the specifications."
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any test set (e.g., number of subjects or samples used in the non-clinical tests like software function, power consumption, etc.).
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified for the non-clinical tests mentioned. Given the manufacturer's location, testing likely occurred in South Korea, but this is not confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The ground truth for a blood glucose monitoring system is typically established against a laboratory reference method (e.g., YSI analyzer) for glucose concentration, not by human experts interpreting results. The document does not mention any expert involvement in establishing ground truth for the non-clinical tests.
4. Adjudication method for the test set
This is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often in imaging or clinical trial contexts. This document describes non-clinical engineering and performance tests for a blood glucose meter.
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. This document describes a continuous glucose monitoring system, not an AI imaging or diagnostic tool that assists human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable in the context of an AI algorithm. This device is a measurement system; its "standalone performance" refers to its accuracy in measuring blood glucose, which is evaluated through specific performance studies (e.g., accuracy against a reference method, precision studies). While these types of studies were undoubtedly performed as part of the overall testing (likely consistent with ISO 15197 for blood glucose monitoring systems, though not explicitly stated in this summary), the details of such quantitative performance studies are not provided in this 510(k) summary. The summary only broadly states that the device "performed as intended and fulfilled the specifications."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a blood glucose monitoring system, the ground truth for glucose measurements is typically established using a laboratory reference method (e.g., YSI glucose analyzer) on venous plasma or serum samples. This is a highly accurate chemical measurement. The document does not explicitly state the ground truth method but this is standard practice for blood glucose meter validation.
8. The sample size for the training set
This is not applicable. This document describes a medical device (blood glucose meter), not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. As above, this is an engineering device, not an AI model with a training set.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.