U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM by TaiDoc Technology Corporation

For single use:
The U-Right TD-4279A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of qlucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-Right TD-4279A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The U-Right TD-4279 A Test Strips are for use with the U-Right TD-4279A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The U-Right TD-4279B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-Right TD-4279B Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The U-Right TD-4279B Test Strips are for use with the U-Right TD-4279B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The FORA GD40a /TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The FORA GD40a / TD-4272A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The FORA GD40a /TD-4272A Test Strips are for use with the FORA GD40a / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The FORA GD40b / TD-4272B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the finqertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The FORA GD40b / TD-4272B Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The FORA GD40b / TD-4272B Test Strips are for use with the FORA GD40b / TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

For multiple patient use:
The U-Right TD-4279A MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The U-Right TD-4279A MULTI Test Strips are for use with the U-Right TD-4279A MULTI Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.
The U-Right TD-4279B MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The U-Right TD-4279B MULTI Test Strips are for use with the U-Right TD-4279B MULTI Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.
The FORA Wisdom GD40a /TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The FORA Wisdom GD40a / TD-4272A Test Strips are for use with the FORA Wisdom GD40a / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.
The FORA Wisdom GD40b / TD-42728 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The FORA Wisdom GD40b / TD-4272B Test Strips are for use with the FORA Wisdom GD40b / TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.

Device Description

The U-RIGHT TD-4279 A/B Blood Glucose Monitoring Systems and FORA GD40a/b Blood Glucose Monitoring Systems consist of three main products: the meter, test strips and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only U-RIGHT TD-4279 A/B test strips and FORA GD40a/b test strips for the U-RIGHT TD-4279 A/B Blood Glucose Monitoring Systems and FORA GD40a/b Blood Glucose Monitoring Systems, and use with FORA control solutions to perform quality checks. The blood glucose detection method and measurement is by an electrochemical biosensor technology using FAD-dependent glucose dehydrogenase (FAD-GDH).

AI/ML Overview

The provided document is a 510(k) summary for several blood glucose monitoring systems. It states that "The laboratory and clinical studies for the system performance of U-RIGHT TD-4279 A/B Blood Glucose Monitoring Systems and FORA GD40a/b Blood -Glucose Monitoring Systems demonstrated the meters and test strips works well as a system." However, it does not provide specific details about the acceptance criteria or the results of these performance studies.

Therefore, I cannot generate the requested table of acceptance criteria and reported device performance or other detailed information about the study. The document primarily focuses on establishing substantial equivalence to a predicate device and outlining the intended use of the devices.

Summary of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document states that performance studies were conducted and "demonstrated the meters and test strips works well as a system," but no specific criteria or results are given.
2. Sample sized 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.
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/provided. For a blood glucose monitoring system, the "ground truth" would typically be established by a reference laboratory method, not by experts adjudicating cases like in imaging studies. However, details of the reference method or how accuracy was determined are not in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.
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 is a standalone diagnostic device, not an AI-assisted reading system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device itself is a standalone system for measuring blood glucose. The performance studies would assess its accuracy against a reference standard. However, the details of these studies are not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a blood glucose meter, the ground truth would typically be established by a highly accurate laboratory reference method (e.g., hexokinase method). However, the specific method used is not mentioned in the document.
8. The sample size for the training set: Not applicable/provided. This device is a traditional electrochemical biosensor, not an AI/ML device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable/provided.

Summary

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JUN 27 2011

K 101509

Attachment C2

510 (k) Summary

Submitter Information Company name Contact person Address

Phone
FAX
E-mail
Date Prepared

Name of Device Trade/Proprietary Name

Common Names Product Code Classification Panel Regulations

TaiDoc Technology Corporation Teling Hsu 3F, 5F, No. 127, Wugong 2nd Rd., Wugu Township, Taipei County, 24888, Taiwan (+886-2) 6625-8188 ext.1176 (+886-2) 6625-0288 teling.hsu@taidoc.com.tw May 315', 2010

U-RIGHT TD-4279A Blood Glucose Monitoring System, U-RIGHT TD-4279B Blood Glucose Monitoring System, U-RIGHT TD-4279A MULTI Blood Glucose Monitoring System, U-RIGHT TD-4279B MULTI Blood Glucose Monitoring System, FORA GD40a/TD-4272A Blood Glucose Monitoring System, FORA GD40b/TD-4272B Blood Glucose Monitoring System, FORA Wisdom GD40a/TD-4272A Blood Glucose Monitoring System and FORA Wisdom GD40b/TD-4272B Blood Glucose Monitoring System Blood glucose test system . NBW, LFR Clinical Chemistry (75) Class II 21 CFR 862.1345

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Predicate Device Trade/Proprietary Name:

Common/Usual Name: Submitter 510 (k) Number

FORA G31 Blood Glucose Monitoring System (Model TD-4256) Blood glucose test system TaiDoc Technology Corporation K094005

4. Device Description

The blood glucose detection method and measurement is by an electrochemical biosensor technology using FAD-dependent glucose dehydrogenase (FAD-GDH).

1. Intended Use

For single use

U-RIGHT TD-4279A Blood Glucose Monitoring System

The U-Right TD-4279A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of qlucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared.

The U-Right TD-4279A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

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The U-Right TD-4279 A Test Strips are for use with the U-Right TD-4279A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

U-RIGHT TD-4279B Blood Glucose Monitoring System

The U-Right TD-4279B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared.

The U-Right TD-4279B Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

The U-Right TD-4279B Test Strips are for use with the U-Right TD-4279B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

FORA GD40a/TD-4272A Blood Glucose Monitoring System

The FORA GD40a /TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared.

The FORA GD40a / TD-4272A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

The FORA GD40a /TD-4272A Test Strips are for use with the FORA GD40a / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

FORA GD40b/TD-4272B Blood Glucose Monitoring System

The FORA GD40b / TD-4272B Blood Glucose Monitoring System is intended to be used

iii

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for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the finqertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared.

The FORA GD40b / TD-4272B Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

The FORA GD40b / TD-4272B Test Strips are for use with the FORA GD40b / TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

For multiple patient use

U-RIGHT TD-4279A MULTI Blood Glucose Monitoring System

The U-Right TD-4279A MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The U-Right TD-4279A MULTI Test Strips are for use with the U-Right TD-4279A MULTI Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.

U-RIGHT TD-4279B MULTI Blood Glucose Monitoring System

The U-Right TD-4279B MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with

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single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The U-Right TD-4279B MULTI Test Strips are for use with the U-Right TD-4279B MULTI Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.

FORA Wisdom GD40a/TD-4272A Blood Glucose Monitoring System

The FORA Wisdom GD40a /TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The FORA Wisdom GD40a / TD-4272A Test Strips are for use with the FORA Wisdom GD40a / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.

FORA Wisdom GD40b/TD-4272B Blood Glucose Monitoring System

The FORA Wisdom GD40b / TD-42728 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The FORA Wisdom GD40b / TD-4272B Test Strips are for use with the FORA Wisdom GD40b / TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.

Comparison to Predicate Device

The U-RIGHT TD-4279 A/B Blood Glucose Monitoring Systems and FORA GD40a/b

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Blood Glucose Monitoring Systems are substantially equivalent to the predicate device FORA G31 Blood Glucose Monitoring System (K094005).

7. Performance Studies

The laboratory and clinical studies for the system performance of U-RIGHT TD-4279 A/B Blood Glucose Monitoring Systems and FORA GD40a/b Blood -Glucose Monitoring Systems demonstrated the meters and test strips works well as a system.

8. Conclusion

The U-RIGHT TD-4279 A/B Blood Glucose Monitoring Systems and FORA GD40a/b Blood Glucose Monitoring Systems demonstrate satisfactory performance and meet its intended use. The U-RIGHT TD-4279 A/B Blood Glucose Monitoring Systems and FORA GD40a/b Blood Glucose Monitoring Systems are substantially equivalent to the predicate devices.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side, and a stylized emblem on the right. The emblem features an abstract design of what appears to be a human figure or symbol, composed of flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

JUN 2 7 2011

Taidoc Technology Corporation c/o Teling Hsu 3f,5f, No.127 Wugong 2nd Rd, Wugu Township, Taipei County, Taiwan 24888

Re: K101509

Trade Name: U-RIGHT TD-4279A Blood Glucose Monitoring System U-RIGHT TD-4279B Blood Glucose Monitoring System U-RIGHT TD-4279A MULTI Blood Glucose Monitoring System U-RIGHT TD-4279B MULTI Blood Glucose Monitoring System FORA GD40a/TD-4272a Blood Glucose Monitoring System FORA GD40b/TD-4272b Blood Glucose Monitoring System FORA Wisdom GD40a/TD-4272a Blood Glucose Monitoring System

FORA Wisdom GD40b/TD-4272b Blood Glucose Monitoring System

Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II

Product Codes: NBW, LFR

Dated: May 31, 2011

Received: June 22, 2011

Dear Ms. Hsu,

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.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Courtney C. Harper, 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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510(k) Number (if known): K101509

Device Name: U-RIGHT TD-4279A Blood Glucose Monitoring System

Indications For Use:

The U-Right TD-4279A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use V .. (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Bener

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101509

Page 1 of 8

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510(k) Number (if known): K101509

Device Name: U-RIGHT TD-4279B Blood Glucose Monitoring System

Indications For Use:

The U-Right TD-4279B Test Strips are for use with the U-Right TD-4279B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use V (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carle Benam

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101507

Page 2 of 8

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510(k) Number (if known): K101509

Device Name:

Indications For Use: FORA GD40a/TD-4272A Blood Glucose Monitoring System

The FORA GD40a/TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared.

The FORA GD40a/TD-4272A Blood Glucose Monitoring System is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

The FORA GD40a/TD-4272A Test Strips are for use with the FORA GD40a / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use V (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Beuer

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K/0/509

Page 3 of 8

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510(k) Number (if known): K101509

Device Name: FORA GD40b/TD-4272B Blood Glucose Monitoring System

Indications For Use:

The FORA GD40b/TD-4272B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared.

The FORA GD40b/TD-4272B Blood Glucose Monitoring System is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

The FORA GD40b/TD-4272B Test Strips are for use with the FORA GD40b/TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Prescription Use (21 CFR Part 801 Subpart D)

Over the Counter Use V (21 CFR Part 801 Subpart C)

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

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol L. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K10/509

Page 4 of 8

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510(k) Number (if known): K101509

Device Name: U-RIGHT TD-4279A MULTI Blood Glucose Monitoring System

Indications For Use:

Prescription Use __ V (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use V (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101509

Page= 5 of 8

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510(k) Number (if known): K101509

Device Name: U-RIGHT TD-4279B MULTI Blood Glucose Monitoring System

Indications For Use:

V Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use V (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol C. Benam

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101509

Page 6 of 8

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510(k) Number (if known): K101509

Device Name: FORA Wisdom GD40a/TD-4272A Blood Glucose Monitoring System

Indications For Use:

The FORA Wisdom GD40a/TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The FORA Wisdom GD40a /TD-4272A Test Strips are for use with the FORA Wisdom GD40a / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use V (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K10/509

Page 7 of 8

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510(k) Number (if known): K101509

Device Name: FORA Wisdom GD40b/TD-4272B Blood Glucose Monitoring System

Indications For Use:

The FORA Wisdom GD40b/TD-4272B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The FORA Wisdom GD40b/TD-4272B Test Strips are for use with the FORA Wisdom GD40b/TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.

V Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use V (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carl C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101509

Page-8 of 8

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.