The system is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. 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 not intended for use on neonates.

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 by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".

Device Description

The CLEVER CHEK TD-3213TM blood glucose and blood pressure measurement system consists of a meter with wrist 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. Also, the system adopts the "oscillometric method" to as the measuring principle and provides the measurement of the systolic and diastolic blood pressure and heart rate of an individual by using a non-invasive technique in which as inflatable cuff is wrapped around the wrist. The pressure sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to determine the systolic and diastolic blood pressure and calculating pulse rate.

AI/ML Overview

I am unable to provide a comprehensive response as the provided text only offers a high-level summary of the device and its intended use, rather than a detailed performance study. The document states "The performance of the CLEVER CHEK TD-3213™ system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the CLEVER CHEK TD-3213TM system is suitable for its intended use" and "The CLEVER CHEK TD-3213™ system demonstrates satisfactory performance and is suitable for their intended uses," but it does not include any specific data, acceptance criteria, sample sizes, or methodologies of these studies.

Therefore, I cannot extract the following information to populate the table and answer your questions:

A table of acceptance criteria and the reported device performance
Sample sizes used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI vs. without AI assistance. (This device is a blood glucose and blood pressure measurement system and does not mention any AI component, hence this question is likely not applicable).
Whether a standalone (algorithm only) performance study was done. (Again, this device does not mention an algorithm in the context of interpretation beyond basic measurement).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The sample size for the training set
How the ground truth for the training set was established

To provide a complete answer to your request, the full performance study report (or at least a detailed summary of its findings, acceptance criteria, and methodology) would be required.

Summary

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Koyrys

MAR 7 - 2005

510 (k) Summary

Page 1-of-3

1. Submitter Information		TaiDoc Technology Corporation
Manufacturer		Shu-Mei Wu
Contact person		4F, No. 88, Sec. 1, Kwang-Fu Rd.,San-Chung, Taipei County, Taiwan
Address
Phone		+886-2-66358080
FAX		+886-2-66355959
E-mail		shumei@taidoc.com.tw
Date Prepared		October 3 , 2004
2. Name of Device
Trade Names		CLEVER CHEK TD-3213TMBlood Glucose and Blood PressureMeasurement System
Common Names/Descriptions		Blood Glucose and Blood Pressure MeasurementSystemBlood Glucose Test Strips
Classification Names		Class II devices21 CFR Section 862.1345, Glucose Test System;21 CFR Section 870.1130, Non-invasive BloodPressure Measurement System
3. Predicate Device
Trade/Proprietary Name:		GLUCOMETER ELITE Diabetes Care SystemAPM Blood Pressure Monitoring System,BP108A
Common/Usual Name:		Blood Glucose Meter; Non-invasive BloodPressure Measurement SystemBlood Glucose Test Strips
Manufacturer		Bayer DiagnosticsAsia Pacific Microsystems, Inc.
510 (k) Number		K020208; K040159

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Page 2-of-3

4. Device Description

5. Intended Uses

The CLEVER CHEK TD-3213™ system is indicated for the quantitative measurement of glucose in fresh whole blood (capillary blood) 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 also intended to use non-invasive measure the systolic and diastolic blood pressure and pulse rate or an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".

6. Comparison to Predicate Device

The CLEVER CHEK TD-3213TM system has equivalent technological characteristics as the GLUCOMETER ELITE Diabetes Care System (K020208) and APM Blood Pressure Monitoring System, BP108A (K040159). The CLEVER CHEK TD-3213TM system also has the same intended use as the GLUCOMETER ELITE Diabetes Care System and APM Blood Pressure Monitoring System, BP108A.

7. Performance Studies

The performance of the CLEVER CHEK TD-3213™ system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the CLEVER CHEK TD-3213TM system is suitable for its intended use

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Page 3-of-3

Conclusions

e: "Concerablems"
The CLEVER CHEK TD-3213™ system demonstrates satisfactory performance and is suitable for their intended uses.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a stacked formation.

MAR 7 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Shu-Mei Wu, Ph.D. Project Manager Taidoc Technology Corporation 4F, 88, Sec.1, Kwang Fu Road San Chung, Taipei China (Taiwan) 241

K042795 Re:

Trade/Device Name: Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX, DXN Dated: January 12, 2005 Received: January 14, 2005

Dear Shu-Mei Wu:

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 cither 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,

Jean M. Cooper MS, DUM

Jean M. Cooper, MS, 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: K042795

Device Name: Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System

Indications For Use:

The Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use.

Prescription Use X (Part 21 CFR 801 Subpart D) (AND)OR

KOL

1 hand and

" "sion Sign-Off)

. Ak) Number _

sion of Clinica!

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Jices

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.