(195 days)
SD GlucoNFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm. SD GlucoNFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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 SD GlucoNFC Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes. The SD GlucoNFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
SD GlucoNFC Blood Glucose Test Strips are for use with SD Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm.
SD GlucoNavii® Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.
SD GlucoNFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm and venous whole blood. The SD GlucoNFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices.
The SD GlucoNFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm and venous whole blood.
SD GlucoNavii® Control Solution is intended for Quality Control of the SD GlucoNFC Multi Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.
SD GlucoNFC Blood Glucose Monitoring System and GlucoNFC Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNFC Blood Glucose Monitoring System is indicated for single-patient use at home (over-the-counter; OTC) and should not be shared, while the SD GlucoNFC Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting (prescription; POC), in order to help monitor the effectiveness of diabetes control. The devices contain near field communication (NFC) technology.
SD GlucoNFC Blood Glucose Monitoring System includes:
- SD GlucoNFC Blood Glucose Meter
- SD GlucoNFC Blood Glucose Test Strips
- SD Glucose Check Strip
- SD GlucoNavii® Control Solution – Level 2
- Lancet
- Lancing device (with a white cap for fingertip testing and a clear cap for Alternative Site Testing)
- User Instruction Guide
- Test Strip Package Insert
- Control Solution Package Insert
SD GlucoNFC Multi Blood Glucose Monitoring System includes
- SD GlucoNFC Multi Blood Glucose Meter
- SD GlucoNFC Multi Blood Glucose Test Strips
- SD Glucose Check Strip
- SD GlucoNavii® Control Solution Level 2
- User Instruction Guide
- Test Strip Package Insert
- Control Solution Package Insert
A drop of blood sample works with Glucose dehydrogenase (GDH) and potassium ferrocyanide in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.
The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: non-meal, pre-meal and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm. The system can also set the pre-meal and post-meal mark. Test results are displayed with mg/dL units. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.
The provided document is a 510(k) Summary for the SD GlucoNFC Blood Glucose Monitoring System and the SD GlucoNFC Multi Blood Glucose Monitoring System. It describes the device, its intended use, comparison to a predicate device, and the non-clinical and clinical tests performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information based on the provided text, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets for each performance metric, nor does it always provide specific numerical results for the device's performance against those criteria. Instead, it generally states that "All the test results met the pre-set criteria."
However, we can infer some criteria and general performance from the "Similarities and Differences" table (Page 7) and the list of conducted tests (Page 9).
| Acceptance Criteria (Inferred from tests and comparisons) | Reported Device Performance (as stated or inferred) |
|---|---|
| Measuring Range | 20-600 mg/dL (Same as predicate) |
| Test Time | 5 seconds (Same as predicate) |
| Operating Temperature (blood sample) | 46-113°F (8-45°C) (Different from predicate, but implies meeting its own criteria) |
| Operating Temperature (control solution) | 64-86°F (18-30°C) (Same as predicate) |
| Operating Humidity | 10-90% RH (Different from predicate, but implies meeting its own criteria) |
| Operating Altitude | Up to 11,548 ft. (Different from predicate, but implies meeting its own criteria) |
| Hematocrit Range | 10-70% (Different from predicate, but implies meeting its own criteria) |
| Memory Capacity | 300 test results (Different from predicate, but deemed "equivalent") |
| Sample Volume | 0.5 µL (Different from predicate, but deemed "equivalent") |
| Coding | Not Applicable (Same as predicate) |
| Unit of Measure | mg/dL (Same as predicate) |
| Electrical Safety | Met pre-set criteria (IEC 61010-1:2001 & IEC 61010-2-101:2002) |
| Electromagnetic Compatibility | Met pre-set criteria (IEC 60601-1-2) |
| Radio Frequency | Met pre-set criteria (FCC Part 15.101) |
| System Accuracy | Met pre-set criteria |
| Precision | Met pre-set criteria |
| Linearity | Met pre-set criteria |
| Matrix comparison | Met pre-set criteria |
| Interference Substances | Met pre-set criteria |
| Disinfection / Virucidal Efficacy Validation | Met pre-set criteria |
| Stability for Test Strip and Control Solution | Met pre-set criteria |
| Readability for proposed labeling | Met pre-set criteria |
| Data accuracy & wireless coexistence | Met pre-set criteria |
| Memory data rollover | Met pre-set criteria |
| Vibration | Met pre-set criteria |
| Software Validation | Met pre-set criteria |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states that "the non-clinical studies and clinical-studies provided in this submission demonstrated that the differences do not raise and effectiveness." The list of tests on page 9 includes "System Accuracy," "Precision," "Linearity," "Sample Volume," "Hematocrit," "Matrix comparison," and "Interference Substances," which typically involve clinical or non-clinical data.
- Sample Size: The document does not specify the sample size used for any of the clinical or non-clinical tests (e.g., system accuracy, precision, linearity).
- Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective. It generally refers to "non-clinical studies and clinical-studies."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document is for a Blood Glucose Monitoring System, which measures a quantitative value (glucose concentration). For such devices, the "ground truth" (or reference method) is typically established using a highly accurate laboratory reference instrument, not by human expert consensus or radiologists.
- Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth, as typically applied to image-based diagnostic systems, does not directly apply here. The ground truth for glucose measurements would be derived from a laboratory reference method.
4. Adjudication Method for the Test Set
As explained above, for a quantitative measurement device like a blood glucose meter, the ground truth is established by a reference laboratory method rather than by human interpretation requiring adjudication.
- Thus, adjudication methods (e.g., 2+1, 3+1) are not relevant to the type of ground truth used for this device.
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
The SD GlucoNFC Blood Glucose Monitoring System is a device designed for direct measurement of blood glucose, not an AI-powered image analysis system that assists human readers in diagnosis.
- Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. There is no mention of AI assistance or human readers improving diagnostic accuracy with the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is a standalone glucose measurement system. The blood glucose meter provides a numerical result directly to the user or healthcare professional. There isn't an "algorithm only" component separate from the meter's function, as the meter itself performs the measurement.
- The performance metrics like "System Accuracy," "Precision," and "Linearity" inherently represent the standalone performance of the device (the meter and test strip system).
7. The Type of Ground Truth Used
For a blood glucose monitoring system, the ground truth is typically established against a laboratory reference method that is highly accurate and precise, often a hexokinase or glucose oxidase method run on a clinical chemistry analyzer.
- The document implies this by stating "System Accuracy" and "Matrix comparison" tests were performed, which compare the device's readings to a known, precise reference. It does not explicitly name the reference method but it's understood in the context of these devices.
- It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document describes premarket notification (510(k)) to demonstrate substantial equivalence, focusing on testing the final device. It does not mention a "training set" in the context of machine learning or AI.
- This device is a traditional electrochemical biosensor, not an AI/ML-based system requiring a distinct training dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of an AI/ML component or a "training set," this question does not apply to the information provided.
§ 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.