(48 days)
The easy check TD-4209/Clever Chek TD-4222/Clever Chek TD-4225/Clever Chek TD-4226 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, and is not intended for use on neonates.
The alternative site testing in the easy check TD-4209/Clever Chek TD-4222/Clever Chek TD-4225/Clever Chek TD-4226 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Not Found
This FDA 510(k) clearance letter pertains to a Blood Glucose Monitoring System, not an AI-powered diagnostic device. Therefore, the requested information regarding AI-specific criteria (such as multi-reader multi-case studies, expert consensus on ground truth for AI, etc.) is not applicable to this document.
However, I can extract information related to the device's intended use and the regulatory approval process. There is no study data or acceptance criteria reported within this document itself, as it is solely the FDA's clearance letter. The letter refers to information provided in the 510(k) submission (which is not included here).
Here's an attempt to answer the applicable parts of your request based on the provided document and general understanding of medical device clearance:
1. A table of acceptance criteria and the reported device performance
- Not provided in the document. This document is a clearance letter, not the submission with the study results. For blood glucose monitoring systems, acceptance criteria typically relate to accuracy standards (e.g., ISO 15197 standards for analytical accuracy) comparing the device's measurements to a laboratory reference method. The "reported device performance" would be the results of the studies demonstrating compliance with these accuracy standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document. This information would be in the 510(k) submission's study reports.
3. 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 applicable / Not provided. For a blood glucose meter, the "ground truth" is typically established by comparing the device's readings to highly accurate laboratory reference methods (e.g., using a YSI glucose analyzer), not through expert interpretation of images or other subjective assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are typically used in studies involving subjective interpretation (e.g., radiology reads) where multiple experts review cases and resolve discrepancies. For a quantitative device like a blood glucose meter, the ground truth is a numerical value from a reference method.
5. 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 standalone blood glucose monitoring system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. A blood glucose meter operates as a standalone device. The "algorithm" here is the chemical reaction and electronic measurement process within the device. Its performance is evaluated independently against a reference method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Likely a highly accurate laboratory reference method. For blood glucose meters, the ground truth is established by obtaining blood glucose measurements using a YSI glucose analyzer or a similar highly precise and accurate laboratory-based method.
8. The sample size for the training set
- Not applicable / Not provided. Blood glucose meters typically do not involve a "training set" in the context of machine learning algorithms. The device is calibrated during manufacturing and its performance validated through clinical studies.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Pi-Shiou Li TaiDoc Technology Corporation 4F, No. 88, Sec. 1, Kwang-Fu Rd. San-Chung, Taipai County Taiwan
SEP 1 9 2006
Re: K062235
Trade/Device Name: easy check TD-4209, Clever Chek TD-4222, Clever Chek TD-4225, Clever Chek TD-4226 Blood Glucose Monitoring System Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: July 31, 2006 Received: August 3, 2006
Dear Ms. Li:
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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G
Alberto Gutierrez, Ph.D. 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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Attachment 2
Indications for Use
510(k) Number: 长0622 35
Device Name: easy check TD-4209, Clever Chek TD-4222, Clever Chek TD-4225, Clever Chek TD-4226 Blood Glucose Monitoring System
Indications for Use:
The easy check TD-4209/Clever Chek TD-4222/Clever Chek TD-4225/Clever Chek TD-4226 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, and is not intended for use on neonates.
The alternative site testing in the easy check TD-4209/Clever Chek TD-4222/Clever Chek TD-4225/Clever Chek TD-4226 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
oncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ice of In Vitro Diagnostic I Evaluation and Safety
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A2
§ 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.