(151 days)
The SuperCheck 1 Blood Glucose Monitoring System, Model 6268, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck 1 Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
The SuperCheck 1 Blood Glucose Monitoring System, Model 6268 consists of a blood glucose meter, blood glucose test strips, control solutions, the lancing device, and lancets. The meter also comes with a speaking function that provides audible test results for users with low vision. The SuperCheck 1 Model 6268 allows the forearm to be used as an alternate site. User performance testing was conducted to support an over-the-counter indication.
Here's a summary of the acceptance criteria and study information for the SuperCheck 1 Blood Glucose Monitoring System, Model 6268, based on the provided 510(k) summary:
Please note: The provided document is a 510(k) summary, which often provides a high-level overview of performance studies without detailing every specific acceptance criterion or the exhaustive data from the studies themselves. Therefore, some requested information (like specific numerical acceptance criteria or full study details) is not explicitly present in the provided text. I will extract what is available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (where available) | Reported Device Performance |
|---|---|---|
| Accuracy / Performance | Demonstrated satisfactory performance for intended use. | Studies demonstrated that the performance of the SuperCheck 1 system meets its intended use. The device is suitable for its intended use and substantially equivalent to the predicate device. |
| Intended Use | Quantitative measurement of glucose in fresh capillary whole blood from the finger and forearm. Use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring effectiveness of a diabetes control program. Not for diagnosis/screening or neonates. Alternative site testing (forearm) only during steady-state blood glucose conditions. | The device fulfilled all aspects of its stated intended use. |
| Equivalency | Equivalent technological characteristics and intended use as the predicate device (Prodigy Voice Blood Glucose Monitoring System). | The SuperCheck 1 has equivalent technological characteristics and intended use as the Prodigy Voice Blood Glucose Monitoring System. |
| Alternate Site Testing | Support for forearm as an alternate site. | User performance testing was conducted to support an over-the-counter indication, including the forearm as an alternate site. |
Missing specific quantitative acceptance criteria: The 510(k) summary does not list specific numerical accuracy or precision acceptance criteria (e.g., % within ±15% of reference, ISO standards for blood glucose meters). It only states that the performance was "satisfactory" and "meets its intended use."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "The performance... was studied in the laboratory and in clinical settings by healthcare professionals and lay users," but does not provide specific numbers for participants or conducted tests.
- Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the submitter's address in Taiwan, it's possible that at least some studies were conducted there, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the 510(k) summary. For blood glucose monitoring systems, ground truth is typically established using a highly accurate reference method (e.g., a laboratory analyzer), rather than expert consensus on images or interpretations.
4. Adjudication Method for the Test Set
- This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert review of medical images or records to establish a consensus ground truth. For a blood glucose meter, ground truth is established by a reference laboratory method, not expert adjudication in this manner.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is measured. For a blood glucose meter, the performance is standalone, measuring the device's accuracy against a reference standard.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone performance study was done. The performance studies described in the summary ("in the laboratory and in clinical settings") relate to the device's ability to accurately measure blood glucose levels by itself. The results are compared directly to a reference method (though the reference method isn't specified in this summary). This is the primary mode of evaluation for a blood glucose monitoring system.
7. The Type of Ground Truth Used
- While not explicitly stated in detail, the ground truth for blood glucose monitoring systems is invariably established by a highly accurate laboratory reference method (e.g., YSI analyzer, hexokinase method). This is the standard practice for evaluating the accuracy of blood glucose meters. It is not expert consensus, pathology, or outcomes data in this context.
8. The Sample Size for the Training Set
- This information is not provided. The 510(k) summary focuses on the performance studies (testing data). Details about the training set size for the device's internal algorithms (e.g., for calibration) are not typically included in these summaries unless they are part of a novel machine learning component that requires extensive training data.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided. Similar to question 8, the details of how any internal algorithms were trained or calibrated, and how their ground truth was established, are not included in this high-level 510(k) summary. It's likely that if a reference method was used for validation (testing), a similar or identical method would have been used for calibration/training.
§ 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.