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.

Device Description

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.

AI/ML Overview

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.

Summary

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UCT 2 5

510 (k) Summary

Submitter Information Company name Contact person Address

Phone FAX E-mail Date Prepared

Name of Device Trade Names

Common Names/Descriptions

Classification Names

Predicate Device Trade/Proprietary Name: Common/Usual Name: Manufacturer 510 (k) Number

Page 1-of-3

TaiDoc Technology Corporation Erica Li 4F, No. 88, Sec. 1, Kwang-Fu Rd, San-Chung, Taipei County, 241, Taiwan (886-2) 6635-8080 (886-2) 6635-5959 erica@taidoc.com May 29th , 2007

Clever Chek TD-4209 Blood glucose monitoring system Clever Chek TD-4222 Blood glucose monitoring system Clever Chek TD-4225 Blood glucose monitoring system Blood Glucose Meter Blood Glucose Test Strips Class II devices (21 CFR Section 862.1345, Glucose Test System)

ACCU-CHEK Aviva test strips Blood Glucose test system Roche Diagnostics K060620

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4. Device Description

5. Intended Use

Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 blood glucose monitoring system is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the finger and the alternative sites for self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities. Testing is done outside the body (in vitro diagnostic use).

The alternative site testing (the plam, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions.

Limited to professionals, this system can also test on neonate blood, where is from the heel.

6. Comparison to Predicate Device

Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 blood glucose monitoring system has equivalent technological characteristics as the ACCU-CHEK Aviva blood glucose test system (K060620). Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 blocd glucose monitoring system also has the similar intended use as the ACCU-CHEK Aviva blood glucose test system

7. Performance Studies

The performance of Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 blood glucose monitoring system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use.

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8. Conclusion

Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 blood glucose monitoring system demonstrates satisfactory performance and is suitable for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

TaiDoc Technology Corporation c/o Ms. Erica Li Management Representative 4F, 88, Sec. 1, Kwang Fu Road San Chung, Taipei County, Taiwan 241

OCT 26 2007

Re: K071493

Trade Name: Clever Chek TD-4209 Blood Glucose Monitoring System, Clever Chek TD-4222 Blood Glucose Monitoring System, Clever Chek TD-4225 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: October 15, 2007 Received: October 18, 2007

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) 276-0490. 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.

Jean 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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Indications for Use

510(k) Number: K071493

Device Name: Clever Chek TD-4209 Blood glucose monitoring system Clever Chek TD-4222 Blood glucose monitoring system Clever Chek TD-4225 Blood glucose monitoring system Indications for Use:

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.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) ·········· (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Carol Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Vision Sign-Off

ිffice of In Vitro Diagnostic Device Evaluation and Safe

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Regulation Number and Section

§ 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.