(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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 3 0 2008
Tyson Bio Rescach, Inc.. c/o Dr. Wen-Hai Tsai (Simon Tsai) Official Correspondent 5F No. 22, Ke E Road III Science-Based Industrial Park Chu-Nan, Miao-Li County 350 Taiwan
K072854 Re:
Trade Name: Diachex Basic Blood Glucose Monitoring System, Diachex Superb, BloodGlucose Monitoring System, Diachex Vigor Blood Glucose Monitoring Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: June 19, 2008 Received: June 19, 2008
Dear Dr. Tsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K072854
DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Device Name: Blood Glucose Monitoring System
Indication For Use:
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.
Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 4079854
§ 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.