(148 days)
The One Drop Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop 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 One Drop Blood Glucose Monitoring System is not for the diagnosis of, or diabetes, and is not intended for use with neonates.
The One Drop Blood Glucose Test Strips:
The One Drop Blood Glucose Test Strips are for use with the One Drop Blood Glucose Meter to quantitatively measure blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The One Drop Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop BGMS 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 not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
The system measures the concentration of glucose in a drop of blood obtained from the fingertip. The test strip is inserted into the meter and the blood is then introduced to the tip of the test strip. The blood reacts with chemicals on the test strip and this reaction generates an electrical current which is measured by the meter. The magnitude of the current is related to the blood glucose concentration. The fundamental scientific technology and the electronics that sends the electrical signals to the assay algorithm are all the same as the predicate device AgaMatrix Jazz Wireless 2 BGMS (K152365). The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.
The One Drop Blood Glucose Monitoring System (BGMS) consists of:
- 1 One Drop Blood Glucose Meter ●
- 1 One Drop Owner's Guide ●
- 1 Carry Case
- 1 Lancing Device
- 10 Lancets
- 100 One Drop Glucose Test Strips ●
- AgaMatrix Glucose Control Solution (available separately) ●
The provided text describes the One Drop Blood Glucose Monitoring System (BGMS) and its submission for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence to a predicate device, the AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (K152365).
Based on the information provided, here is the breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list "acceptance criteria" for the device's performance in a table format with corresponding "reported device performance." Instead, it establishes substantial equivalence by demonstrating that the One Drop BGMS has the same performance characteristics as the predicate device. The performance characteristics are implicitly considered "acceptance criteria" because they mirror those of the already-cleared predicate.
| Performance Characteristic | Acceptance Criteria (from Predicate) | Reported Device Performance (One Drop BGMS) |
|---|---|---|
| Sample Type | Capillary whole blood | Same |
| Sample Sites | Fingertip | Same |
| Sample Volume | 0.5 µL | Same |
| Average Test Time | 5 seconds | Same |
| Test Range | 20 - 600 mg/dL | Same |
| Operating Temperature | 50° - 104°F | Same |
| Measurement Range | 20 to 600 mg/dL | Same |
| Calibration | Plasma Equivalent | Same |
| Control Levels | Two Levels | Same |
| Operating Humidity | 10% to 90% | Same |
| Hematocrit Range | 20 - 60% | Same |
| Altitude Study | Up to 10,000 feet | Same |
| Power Source | (2) replaceable CR2032 3 volt, lithium batteries | Same |
| Connectivity | Meter can send BGM results via Bluetooth to smart devices using appropriate iOS or Android software application. | Same |
| Detection method | Dynamic Electrochemistry | Same |
| Enzyme | Glucose Oxidase | Same |
| Calibration Coding | Non-Coding | Same |
The document explicitly states: "The fundamental scientific technology and the electronics that sends the electrical signals to the assay algorithm are all the same as the predicate device AgaMatrix Jazz Wireless 2 BGMS (K152365)." And "The device modifications described in this premarket notification do not affect or alter the fundamental scientific technology of the predicate device, the AgaMatrix Jazz Wireless 2 Blood Glucose Monitor." This implies that the device's performance is expected to be identical to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for any performance testing of the One Drop BGMS, nor does it provide information on data provenance (e.g., country of origin, retrospective or prospective). The document relies on demonstrating substantial equivalence to the predicate device, implying that extensive de novo testing that would require such details might not have been included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a submission for a blood glucose monitoring system, the "ground truth" for glucose measurements is typically established through a laboratory reference method (e.g., YSI analyzer) performed by trained laboratory technicians, not clinical "experts" in the sense of radiologists.
The document does not provide details on the number of laboratory personnel or their specific qualifications for establishing the ground truth for any testing conducted for the One Drop BGMS.
4. Adjudication Method for the Test Set
As the "ground truth" for blood glucose measurements is generally an objective laboratory reference method, an "adjudication method" involving multiple human readers as described (e.g., 2+1, 3+1) is not applicable to this type of device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is relevant for devices where human interpretation plays a significant role in diagnosis or decision-making (e.g., imaging studies). For a blood glucose monitoring system, which provides a direct numerical reading, an MRMC study comparing human readers with and without AI assistance is not applicable. The device is intended for self-testing by individuals with diabetes, not for interpretation by multiple clinical experts.
6. Standalone Performance Study
The provided document does not explicitly describe a standalone (algorithm only) performance study for the One Drop BGMS with detailed metrics. The submission focuses on establishing substantial equivalence to a predicate device, which implies that the underlying technology's standalone performance characteristics were already validated with the predicate. The document states that the fundamental scientific technology and electronics are the same as the predicate.
7. Type of Ground Truth Used
For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method for glucose measurement, such as a YSI glucose analyzer, which provides highly accurate and precise glucose values in blood samples. Details of this are not explicitly stated for the One Drop BGMS but would be standard for this type of device.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for any training set. Given the focus on substantial equivalence, if machine learning or AI was used in the development (which is not explicitly stated beyond "assay algorithm"), the training details are not disclosed in this summary.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any training set was established. As with testing, if a training set were used for an algorithm, the ground truth would typically be established by a laboratory reference method.
§ 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.