(216 days)
The Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood collected from the fingertip. The Sejoy Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Advance Link Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Sejoy Advance Link Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips, and the Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Control Solutions, and the Sejoy Lancing Device with Sejoy disposable safety lancets (K222034, manufactured independently by Beijing Ruicheng Medical Supplies Co. Ltd. and cleared under 510(k)) are for use with the system and could sold separately.
The Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Meter differ only in Bluetooth functionality which is present only in the Sejoy Advance Link Blood Glucose Meter.
The system measures glucose using amperometric technology and features glucose dehydrogenase in the test strip, interacting with glucose in the blood to produce an electrical current. This current is directly proportional to the blood glucose concentration, converted into values by the system software. The result is displayed on the meter's LCD in plasma value equivalence (mg/dL) and is automatically stored.
The provided document describes the Sejoy Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System and their substantial equivalence to a predicate device. Information relevant to acceptance criteria and study proving performance is extracted below.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood glucose monitoring systems are primarily based on accuracy compared to a lab reference method. The document specifies accuracy levels at various percentage tolerances.
| Accuracy Tolerance | Acceptance Criterion (Implicit) | Reported Device Performance (Overall) | Reported Device Performance (Glucose 250 mg/dL) |
|---|---|---|---|---|
| Within ±5% | N/A (Often implies higher percentages) | 56.8% (200/352) | 54.0% (27/50) | 60.0% (30/50) |
| Within ±10% | N/A (Often implies higher percentages) | 90.3% (318/352) | 92.0% (46/50) | 96.0% (48/50) |
| Within ±15% | N/A (Often implies higher percentages) | 98.3% (346/352) | 100.0% (50/50) | 100.0% (50/50) |
| Within ±20% | N/A (Often implies higher percentages) | 100% (352/352) | 100.0% (50/50) | 100.0% (50/50) |
Note: The document states "Sejoy Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System were designed and tested in accordance with FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (September 2020)." This guidance typically sets specific accuracy criteria (e.g., within ±15% for a certain percentage of samples). While the exact numerical criteria from the FDA guidance are not explicitly stated in the provided text, the reported performance metrics clearly indicate the device's adherence to such guidelines, as implied by the phrase "sufficiently accurate."
2. Sample Size Used for the Test Set and Data Provenance
- Overall Test Set Sample Size: 352 lay persons (for the user evaluation study).
- Extreme Glucose Concentrations Test Set Sample Size: 50 subjects for low blood glucose (250 mg/dL), totaling 100 subjects for this specific sub-study.
- Data Provenance: The document does not explicitly state the country of origin for the data, but it refers to "lay persons representative of the age, gender, education of the intended users in the US," suggesting the study subjects were recruited in the US. The study was a prospective user performance evaluation where subjects self-tested their capillary whole blood.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established using a laboratory reference method, the YSI 2300 STAT PLUS glucose analyzer, which is a highly accurate and standardized instrument. There is no mention of experts being used to establish the ground truth for the test set, as the YSI analyzer itself serves as the gold standard.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by a laboratory reference instrument (YSI 2300), not by human readers requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation tool. The study involved users operating the device, not interpreting images with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, analytical performance testing was conducted which can be considered analogous to "standalone" performance for such a device. This included:
- Repeatability
- Intermediate precision
- Hematocrit effect
- Short sample volume
- Perturbation
- Interference
- Linearity testing
These tests evaluate the intrinsic performance of the device's measurement algorithm and hardware components, independent of human operation variability.
7. The Type of Ground Truth Used
The ground truth was established using a laboratory reference method: the Yellow Springs Instrument (YSI 2300 STAT PLUS glucose analyzer). The document specifies "capillary plasma" for the YSI 2300 reference, indicating a highly accurate and controlled measurement.
8. The Sample Size for the Training Set
The document describes performance evaluation studies (user evaluation and extreme glucose concentration studies) which are typically "test set" studies for device clearance. It does not provide information on the sample size used for the training set of the device's internal algorithms, as this detail is generally considered proprietary to the manufacturer and not typically included in a 510(k) summary unless the device heavily relies on a continuously learning AI model that requires explicit training data disclosure in the submission. For a blood glucose meter, the "training" (calibration and optimization) of its algorithms is usually done during the device's development phase rather than through a distinct "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Since information about a specific "training set" is not provided, the method for establishing its ground truth is also not detailed. However, for a device like a blood glucose meter, the internal algorithms and calibration are established using highly controlled laboratory experiments and reference methods (like YSI 2300) during the design and development phase to ensure accuracy across the measurement range and various physiological conditions.
§ 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.