(149 days)
The Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 Blood glucose monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus.
The alternative site testing in the Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.
Professionals may use the Clever Chek TD-4209/ Clever Chek TD-4222 Blood/ Clever Chek TD-4225 glucose monitoring system to test neonatal blood ' from the heel, but may not be used in screening for neonatal hypoqlycemia.
Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 blood glucose monitoring system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
This 510(k) summary for the Clever Chek TD-4209/4222/4225 Blood Glucose Monitoring System is very brief and does not include detailed performance study information typically found in such submissions. Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "The studies demonstrated that the performance of this system meets its intended use." However, it does not provide any specific quantitative acceptance criteria or detailed reported device performance values (e.g., accuracy against a reference method, precision statistics, error grid analysis results).
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Not explicitly stated in the document) |
|---|---|
| (Likely based on ISO 15197 or similar standards for glucose meters, but not detailed here) | "satisfactory performance" and "meets its intended use" |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document states "studied in the laboratory and in clinical settings by healthcare professionals and lay users," but no numbers are given for the number of participants or samples.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Blood glucose meter performance studies typically uses a laboratory reference method (e.g., YSI analyzer) as the ground truth, not human experts.
4. Adjudication method for the test set:
Not applicable for a blood glucose meter study, as ground truth is typically established by a laboratory reference instrument, not by expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret medical images. Blood glucose meters are autonomous devices.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, implicitly. The "performance studies" section refers to the evaluation of the "system" (meter and test strips). Blood glucose meters are standalone devices that provide a direct reading without human interpretation of raw data. The performance studies would have evaluated the accuracy of these readings compared to a reference method.
7. The type of ground truth used:
While not explicitly stated, for blood glucose meters, the ground truth is almost universally established using a laboratory reference method (e.g., a YSI STAT PLUS Glucose & Lactate Analyzer). The document only generally states "Performance Studies."
8. The sample size for the training set:
Blood glucose meters are typically designed and calibrated based on biochemical principles and pre-existing knowledge of glucose-electrode reactions. They do not usually involve a "training set" in the machine learning sense of the term. If any data was used for internal calibration or optimization, its size is not specified.
9. How the ground truth for the training set was established:
As mentioned above, the concept of a "training set" with established ground truth in the machine learning sense is generally not applicable to the development of electrochemical blood glucose meters. Development involves calibration against known glucose concentrations using a reference method.
Summary of missing key information:
This 510(k) summary is extremely high-level regarding performance studies. Critical information that would typically be expected includes:
- Specific accuracy standards (e.g., ISO 15197:2003 or later versions).
- Quantitative accuracy data (e.g., mean absolute relative difference, percentage of results within specific error grids, Bland-Altman plots).
- Precision data (e.g., coefficient of variation for within-run and total precision).
- Interference studies (e.g., effects of hematocrit, specific medications).
- Detailed participant demographics for clinical studies (number of subjects, age, diabetes type).
- Details of the reference method used.
§ 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.