(240 days)
The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The PRECICHEK Cloudia 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 PRECICHEK Cloudia Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The PRECICHEK ACH Blood Glucose Test Strips are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The PRECICHEK Glucose Control Solutions are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System and PRECICHEK ACH Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
PRECICHEK Cloudia Blood Glucose Monitoring System consists of:
- (1)Glucose Meter
- (2)Glucose Test Strips
- (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
- (4)Check Strip
- (5)Instruction for use
[Test Principle]
PRECICHEK Cloudia Blood Glucose Monitoring System is an electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.
[Control Solution]
The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the PRECICHEK Cloudia Blood Glucose monitoring system and PRECICHEK ACH Blood Glucose Test strips. There are two levels of controls (Levels 1,2).
[Check Strip]
The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.
[Device Calibration]
The device is calibrated by implicit coding process. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.
The PRECICHEK Cloudia Blood Glucose Monitoring System acceptance criteria and study information are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the device is compliant with ISO 15197:2003. This standard specifies requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. Therefore, the acceptance criteria are those defined by ISO 15197:2003. While the specific numerical performance metrics are not detailed in the provided text, the overall statement of compliance implies that the device met these criteria.
| Acceptance Criteria (Based on ISO 15197:2003) | Reported Device Performance |
|---|---|
| Met the requirements of ISO 15197:2003 for in vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. | "All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set. It also does not provide details on the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts used to establish the ground truth or their qualifications. It only states, "All the relevant activities were performed by professionals."
4. Adjudication Method for the Test Set:
The document does not describe the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No mention of an MRMC comparative effectiveness study or any effect size regarding human readers improving with AI vs without AI assistance. This device is a blood glucose monitoring system and does not involve AI assistance for human readers in diagnostic interpretation.
6. Standalone Performance Study:
Since this is a blood glucose monitoring system, the performance described relates to the accuracy and precision of the device itself (algorithm only without human-in-the-loop diagnostic interpretation). The document indicates that the device's performance was evaluated against the ISO 15197:2003 standard, which assesses the standalone performance of the system for measuring glucose.
7. Type of Ground Truth Used:
The ground truth for evaluating the PRECICHEK Cloudia Blood Glucose Monitoring System would typically be established by a reference laboratory method (e.g., a laboratory glucose analyzer) that is traceable to an accepted standard, as per the ISO 15197:2003 guidelines for blood glucose meters. While not explicitly stated, this is the standard practice for such devices.
8. Sample Size for the Training Set:
The document does not specify a training set sample size. For a medical device like a blood glucose meter, the "training set" would likely refer to the data used during the development and calibration phases, rather than a distinct 'training set' in the machine learning sense. This detail is not provided.
9. How the Ground Truth for the Training Set was Established:
The document does not provide details on how the ground truth for any potential "training set" was established, beyond the general adherence to ISO 15197:2003 for performance evaluation. Calibration of blood glucose meters typically involves comparing the device's readings against highly accurate laboratory reference methods across a range of glucose concentrations.
§ 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.