K Number
K062800
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 BLO
Date Cleared
2007-01-12

(115 days)

Product Code
Regulation Number
862.1345
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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.
More Information

Not Found

No
The document describes standard electrochemical and oscillometric methods for glucose and blood pressure measurement, with no mention of AI or ML technologies.

No
The device is intended for monitoring blood glucose and blood pressure, which are diagnostic and monitoring functions, not therapeutic. It aids in monitoring a diabetes control program, but does not provide therapy itself.

No

The "Intended Use / Indications for Use" section explicitly states, "It is not intended for the diagnosis of or screening for diabetes mellitus." While it measures glucose and blood pressure, its purpose is for monitoring effectiveness of diabetes control and general blood pressure/pulse rate rather than diagnosing conditions.

No

The device description explicitly states that the system consists of a monitor with wrist/arm cuff and test strips, which are hardware components.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The device is intended for the "quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites...". This involves testing a biological sample (blood) in vitro (outside the body) to obtain a diagnostic measurement (glucose level).
  • Device Description: The description explicitly states the system "utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing." This is a common method used in IVD devices for chemical analysis of biological samples.
  • Aid in Monitoring: The intended use states it is "as an aid in monitoring the effectiveness of diabetes control program." While not for diagnosis, monitoring glucose levels is a key aspect of managing diabetes, which relies on in vitro testing.

The blood pressure monitoring function is a separate component and is not an IVD function, as it is a non-invasive measurement of a physiological parameter. However, the inclusion of the blood glucose measurement component makes the overall system an IVD.

N/A

Intended Use / Indications for 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 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".

Product codes (comma separated list FDA assigned to the subject device)

NBW, CGA, DXN

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" (2435 cm) for arm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Glucose: fresh capillary whole blood from the finger, the palm, the forearm, the upper-arm, the calf and the thigh.
Blood Pressure: wrist, arm

Indicated Patient Age Range

adult individual, over age 16. Not intended for use on neonates.

Intended User / Care Setting

self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K061181, K042795, K061073

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

510 (k) Summary

K062800

ട്ടിക്കുന്നു. 2007

1.Company Information
Company nameTaiDoc Technology Corporation
Contact personPi-Shiou Li
Address4F, No.88, Sec. 1, Kwang-Fu RD.,
San-Chung, Taipei County, Taiwan, R.O.C., 241
Phone886-2-6635-8080
E-mailerica@taidoc.com
FAX886-2-6635-5959

2. Device Identification

| Trade name | Clever Chek TD-3213 Blood Glucose plus Blood Pressure
Monitoring System
Clever Chek TD-3215 Blood Glucose plus Blood Pressure
Monitoring System
Dr. T TD-3216 Blood Glucose plus Blood Pressure
Monitoring System
Clever Chek TD-3217 Blood Glucose plus Blood Pressure
Monitoring System
Clever Chek TD-3250 Blood Glucose plus Blood Pressure
Monitoring System |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name | Blood Glucose and Blood Pressure Measurement System
Blood Glucose Test Strip |
| Classification name | Class II devices
21 CFR Section 862.1345, Glucose Test System
21 CFR Section 870.1130, Non-invasive Blood Pressure
Measurement System |

3. Predicate Device

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

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4. 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" (2435 cm) for arm.

    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-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

2

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.

3

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

5

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 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".

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

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Office of In Vitro Diagnostic Device Evaluation and Safety

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