The Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose plus Blood Pressure 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 systems can be used only during steady-state blood glucose conditions.

The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home.

For Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217 system, the blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25″ ~ 7.75″ .

For Clever Chek TD-3250 system, the blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" ~ 13.8".

Device Description

The Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose plus Blood Pressure Monitoring System consists of a monitor with wrist/arm cuff 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.

The system is able to provide blood pressure measurement which adopts the "oscillometric method" as the measuring principle. It provides the systolic pressure, diastolic blood pressure and pulse rate on an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist (Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217) or in the arm (Clever Chek TD-3250). The cuff circumference is limited to 5.25" ~7.75" (13 ~20 cm) for wrist or 9.4"~~13.8" (24~~35 cm) for arm.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt. The document is a 510(k) summary for a medical device, which typically provides an overview of the device and its equivalence to predicate devices, rather than an in-depth scientific study.

However, based on the information available, I can extract what is mentioned:

1. A table of acceptance criteria and the reported device performance:

The document broadly states that "The performance of the Clever Chek TD-3213... Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the above blood glucose plus blood pressure monitoring system is suitable for its intended use."

It does not provide specific numerical acceptance criteria (e.g., accuracy percentages, precision metrics) or the reported device performance against those criteria. It only offers a general conclusion of satisfactory performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified for any test set.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The company address is in Taiwan, but this doesn't confirm the study location.

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 specified. The document mentions "healthcare professionals" participated in clinical settings, but no details on their number or qualifications for establishing ground truth are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

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 blood glucose and blood pressure monitoring system, not an AI-assisted diagnostic imaging device requiring human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The device itself is a "standalone" measurement system for blood glucose and blood pressure in the sense that it provides direct readings without human interpretation of complex data (like an imaging algorithm). However, the document doesn't explicitly describe a "standalone performance study" in the context of an algorithm's performance vs. human interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For blood glucose measurements, standard practice would involve comparison to a laboratory reference method (e.g., a YSI analyzer), which serves as the "ground truth." For blood pressure, a validated reference sphygmomanometer would be the ground truth. However, the document does not explicitly state what "ground truth" methods were used.

8. The sample size for the training set:

Not applicable or not specified. This device is not described as involving a machine learning algorithm that requires a "training set" in the conventional sense. Its function relies on electrochemical and oscillometric methods, not AI training.

9. How the ground truth for the training set was established:

Not applicable, as no training set for an AI algorithm is mentioned.

Summary of available information related to performance:

The document states:

"The performance of the Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose plus Blood Pressure Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users."
"The studies demonstrated that the above blood glucose plus blood pressure monitoring system is suitable for its intended use."
"The Clever Chek TD-3213... Monitoring System demonstrates satisfactory performance and is suitable for their intended use."

This is a high-level summary confirming that performance studies were conducted and the device met its intended use, but it lacks the specific details of acceptance criteria and study methodologies requested.

Summary

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510 (k) Summary

K062800

ട്ടിക്കുന്നു. 2007

1.	Company Information
	Company name	TaiDoc Technology Corporation
	Contact person	Pi-Shiou Li
	Address	4F, No.88, Sec. 1, Kwang-Fu RD.,San-Chung, Taipei County, Taiwan, R.O.C., 241
	Phone	886-2-6635-8080
	E-mail	erica@taidoc.com
	FAX	886-2-6635-5959

・

2. Device Identification

Trade name	Clever Chek TD-3213 Blood Glucose plus Blood PressureMonitoring SystemClever Chek TD-3215 Blood Glucose plus Blood PressureMonitoring SystemDr. T TD-3216 Blood Glucose plus Blood PressureMonitoring SystemClever Chek TD-3217 Blood Glucose plus Blood PressureMonitoring SystemClever Chek TD-3250 Blood Glucose plus Blood PressureMonitoring System
Common name	Blood Glucose and Blood Pressure Measurement SystemBlood Glucose Test Strip
Classification name	Class II devices21 CFR Section 862.1345, Glucose Test System21 CFR Section 870.1130, Non-invasive Blood PressureMeasurement System

3. Predicate Device

K061181	ACHTUNG Blood Glucose Monitoring System by TaiDocTechnology Corporation.
K042795	Clever Chek TD-3213 Blood Glucose and Blood PressureMeasurement System by TaiDoc Technology Corporation.
K061073	Clever Chek TD-3250 Blood Glucose and Blood PressureMeasurement System by TaiDoc Technology Corporation.

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4. Device Description

1. Intended Use
  The Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose plus Blood Pressure Monitoring System is indicated for the quantitative measurement of glucose in fresh whole blood (capillary blood from the finger, the palm, the forearm, the upper-arm, the calf and the thigh) 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 system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home.

For Clever Chek TD-3250 system, the blood pressure is measured by using

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a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" ~ 13.8".

1. Comparison to Predicate Device
  The Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose plus Blood Pressure Monitoring System has equivalent technological characteristics as the ACHTUNG Blood Glucose Monitoring System (K061181), the Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System (K042795) and the the Clever Chek TD-3250 Blood Glucose and Blood Pressure Measurement System (K061073).

The system also contains the same intended use as the ACHTUNG Blood Glucose Monitoring System (K061181), the Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System (K042795) and the the Clever Chek TD-3250 Blood Glucose and Blood Pressure Measurement System (K061073).

1. Performance Studies
  The performance of the Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose plus Blood Pressure Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the above blood glucose plus blood pressure monitoring system is suitable for its intended use.
1. Conclusion
  The Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose plus Blood Pressure Monitoring System demonstrates satisfactory performance and is suitable for their intended use.

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Image /page/3/Picture/1 description: The image shows the logo of the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, symbolizing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 3 1 2007

Taidoc Technology Corporation 4F, 88, Sec.1, Kwang Fu Road San Chung, Taipei 241 China (Taiwan) ATTN: Ms. Pi-Shiou Li

Re: K062800

Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose plus Blood Pressure Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, DXN Dated: December 28, 2006 Received: January 03, 2007

Dear Ms. Li:

This letter corrects our substantially equivalent letter of January 22, 2007.

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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Page 2 -

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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Indications for Use

510(k) Number:

Device Name: Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216 Clever Chek TD-3217/Clever Chek TD-3250 Blood Glucose plus Blood Pressure Monitoring System

Indications for Use:

The alternative site testing in the systems can be used only during steady-state blood glucose conditions.

The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home.

For Clever Chek TD-3250 system, the blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" ~ 13.8".

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

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

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

Carl Benson
Division Sign-Off

iii

Office of In Vitro Diagnostic Device Evaluation and Safety

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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.