(269 days)
The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.
Not Found
This letter from the FDA does not contain enough information to complete all sections of your request. It primarily provides a "substantial equivalence" determination based on a 510(k) premarket notification. While it confirms the device's intended use and classification, it does not include detailed study results, acceptance criteria, sample sizes, or ground truth establishment methods. These details are typically found in the actual 510(k) submission document itself, not in the FDA's clearance letter.
Therefore, I can only provide limited information based on the text provided.
Acceptance Criteria and Study Details for Diachex Basic/Superb/Vigor Blood Glucose Monitoring System
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the provided FDA letter.
- Reported Device Performance: Not explicitly stated in the provided FDA letter.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified in the provided FDA letter.
- Data Provenance: Not specified in the provided FDA letter. The device manufacturer is Tyson Bio Research, Inc. in Taiwan, suggesting the studies could have been conducted there, but this is not confirmed. The letter refers to a "premarket notification" which would contain this information.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not specified in the provided FDA letter.
4. Adjudication Method for the Test Set
- Not specified in the provided FDA letter.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Not applicable/Not mentioned. Blood glucose monitoring systems typically undergo analytical and clinical performance studies, not MRMC studies in the way medical imaging AI often does.
6. If a Standalone (Algorithm Only) Performance Was Done
- Not applicable/Relevant for a blood glucose monitoring system, as performance relates to the integrated system (meter, strip, blood sample).
7. Type of Ground Truth Used
- Not specified in the provided FDA letter. For blood glucose meters, the ground truth for performance studies is typically established using a reference laboratory method (e.g., YSI instrument) for glucose measurement on the same blood samples.
8. Sample Size for the Training Set
- Not specified in the provided FDA letter.
9. How the Ground Truth for the Training Set Was Established
- Not specified in the provided FDA letter.
Summary of Missing Information:
To answer your request comprehensively, the detailed 510(k) submission (K072854) document would be required. This document typically contains:
- Specific performance claims (e.g., accuracy percentages within certain glucose ranges)
- The clinical study design, including sample sizes, subject demographics, and inclusion/exclusion criteria.
- Comparisons to a reference method (ground truth) and the methodology for establishing that ground truth.
- Statistical analysis and raw data.
§ 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.