(163 days)
The 3test® Glucose test strip is intended to measure the glucose in whole blood with the 3test® Glucose Monitoring System. It is suitable for a person with diabetes to monitor their blood glucose at home by themselves. The 3test® Glucose Monitoring System can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood.
NOTE:
a. the 3test is to be used with capillary whole blood from the fingertip
b. the 3test is not for use with neonates
b. the stest meter is to be used with the 3test Blood Glucose Test Strip, and the 3test High and Low Glucose Control Solutions
Based on an electrochemical biosensor technology and the principle of capillary action, 3test® Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and is displayed in 5 seconds, and 100 blood glucose result memory.
Here's an analysis of the provided text regarding the 3test® Glucose Monitoring System, focusing on the acceptance criteria and the study that proves the device meets those criteria:
The provided text does not include specific acceptance criteria or the full study details that would typically be found in a comprehensive medical device submission. It primarily focuses on the device's administrative details, its intended use, and its claim of substantial equivalence to a predicate device.
However, based on the information provided, we can infer some aspects and highlight what's missing:
Acceptance Criteria and Reported Device Performance
The document states, "your blood glucose result is precisely and displayed in 5 seconds." This implies a performance claim related to speed and accuracy, but it doesn't quantify "precisely" with specific numerical acceptance criteria (e.g., accuracy within a certain percentage of a reference method).
Inferred Acceptance Criteria & Reported Performance (Based on limited information):
Acceptance Criteria (Inferred) | Reported Device Performance (From Text) |
---|---|
Blood glucose measurement speed | Displays results in 5 seconds |
Blood glucose measurement accuracy | "Precisely" (Lacks specific numerical parameters like bias, CV, or percentage within a certain range of a reference method, as typically required). |
Memory capacity for blood glucose results | 100 blood glucose result memory |
Compatibility with blood sample type | Uses whole blood (capillary whole blood from the fingertip) |
Suitability for home use by individuals with diabetes | Intended for self-monitoring at home by persons with diabetes |
Suitability for clinical use by professionals | Can be used at clinical sites by nurses or professional people |
Not for neonatal use | Specifically states "not for use with neonates" |
Compatibility with specific components | To be used with 3test Blood Glucose Test Strip, and 3test High and Low Glucose Control Solutions |
Key Missing Information for Acceptance Criteria:
- Numerical Accuracy Targets: The most critical missing piece is the quantitative acceptance criteria for accuracy (e.g., ISO 15197 standards like 95% of results within ±15 mg/dL or ±15% of a reference method for concentrations >100 mg/dL).
- Precision/Repeatability/Reproducibility: No data on the variability of the device's measurements.
- Interference Studies: No mention of testing for interference from common substances in blood.
- User Performance Studies (for home use): No details on studies demonstrating that lay users can operate the device correctly and achieve accurate results.
- Linearity/Measuring Range: The range of blood glucose values over which the device is accurate is not specified.
Study Information:
The document broadly mentions "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System." However, it does not provide any specific details about these studies.
Here's a breakdown of what we can and cannot answer based on the provided text:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The text does not mention the sample size for any clinical or pre-clinical studies, nor does it specify the data provenance (e.g., country, retrospective/prospective nature).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. The document makes no reference to experts or the establishment of ground truth for any test sets. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method, not expert consensus as in imaging.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where subjective interpretation is involved. For a quantitative device like a blood glucose meter, ground truth is usually an objective lab reference measurement, not a consensus among experts. No such method is mentioned.
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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.
- Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases. Therefore, an MRMC study is not relevant to this technology.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
- Implied, but details are missing. A blood glucose meter inherently operates as a standalone device to measure glucose levels. Its "performance" would be the accuracy of its measurement against a reference. However, the study details validating this standalone performance (e.g., against a laboratory analyzer) are not provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but inferred to be a laboratory reference method. For a blood glucose meter, the "ground truth" for clinical studies would typically be a highly accurate and precise laboratory reference method (e.g., hexokinase method on a clinical chemistry analyzer). The document does not describe how ground truth was established, only that "Pre-clinical and clinical data are employed."
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The sample size for the training set.
- Not applicable/Not provided. Blood glucose meters based on electrochemical biosensor technology generally do not employ machine learning algorithms that require a "training set" in the conventional sense of AI/ML. Their performance is based on the chemical and electrical properties of the test strip and meter. If there were any internal calibration or factory adjustments involving data, it's not described as a "training set."
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How the ground truth for the training set was established.
- Not applicable/Not provided for the same reasons as point 7.
§ 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.