FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244

• K Number: K093035
• Device Name: FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
• Manufacturer: TaiDoc Technology Corporation
• Date Cleared: 2009-12-24 ( 85 days)
• Product Code: NBW CGA
• Regulation Number: 862.1345

Intended Use

The FORA V10 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, and is not intended for use on neonates. The alternative site testing in the FORA V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Device Description

The FORA V10 Blood Glucose Monitoring System consists of Glucose meter, Test Strips, Two levels of Control Solution, commercially available Lancing Device and Sterile Lancets, User Manual, and Storage Pack.

Predicate Devices

K090404

Reference Devices

K090404

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.

Therapeutic

No
This device is a blood glucose monitoring system, which is used for diagnostic and monitoring purposes, not for direct treatment or therapy.

Diagnostic

No

The "Intended Use / Indications for Use" section explicitly states, "It is not intended for the diagnosis of or screening for diabetes mellitus".

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a Glucose meter, Test Strips, Control Solution, Lancing Device, and Sterile Lancets, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use explicitly states it is for the "quantitative measurement of glucose in fresh capillary whole blood". This is a measurement performed in vitro (outside the body) on a biological sample (blood).
• Device Description: The system includes components like "Test Strips" and "Control Solution", which are typical reagents and materials used in in vitro diagnostic testing.
• Performance Studies: The performance studies mention laboratory tests and meeting the requirements of ISO 15197, which is a standard specifically for in vitro diagnostic test systems for self-testing of blood glucose in managing diabetes mellitus.

Therefore, based on the provided information, the FORA V10 Blood Glucose Monitoring System clearly fits the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FORA V10 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, and is not intended for use on neonates. The alternative site testing in the FORA V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Product codes

NBW, CGA

Device Description

The FORA V10 Blood Glucose Monitoring System consists of Glucose meter, Test Strips, Two levels of Control Solution, commercially available Lancing Device and Sterile Lancets, User Manual, and Storage Pack.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

finger, palm, forearm, upper-arm, calf, thigh

Indicated Patient Age Range

Not intended for use on neonates.

Intended User / Care Setting

healthcare professionals and people with diabetes mellitus at home

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

A comparison of precision and system accuracy performance demonstrated that the FORA V10 Blood Glucose Monitoring System and the currently marketed FORA V10 Blood Glucose Monitoring System are substantially equivalent, the laboratory tests showed that the device met the requirements of ISO 15197. Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA V10 Blood Glucose Monitoring System are equivalent to the predicate device.

Key Metrics

Not Found

Predicate Device(s)

K090404

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is:

• DEC 2 4 2009 1. Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
  Correspondence: Debra Liang Regulatory Affairs Specialist Tel: [phone] #1198 Fax: [phone] Email: [e-mail]

• 2. Device name:
     Proprietary name: FORA V10 Blood Glucose Monitoring System, model TD-4244

Regulatory information:

• Regulation section: 21 CFR 862.1345 Glucose Test Systems A.
• Classification: B. Class II
• CGA, Glucose Oxidase, Glucose Product Code: . C. NBW, System, Test, Blood Glucose, Over the Counter D. Panel: Chemistry (75)
• 3. Intended Use:

The FORA V10 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.

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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 FORA V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

• 4. Device Description: ·
     The FORA V10 Blood Glucose Monitoring System consists of Glucose meter, Test Strips, Two levels of Control Solution, commercially available Lancing Device and Sterile Lancets, User Manual, and Storage Pack.
• 5. Substantial Equivalance Information:
     Predicate device name: A. Fora V10 Blood Glucose Monitoring System, Model TD-4244

B. Predicate K number: K090404

C. Comparison with predicate:

The modified FORA V10 Blood Glucose Monitoring System has the following similarities to the predicate device:

• Same intended use
• Same operating principle,
• l Same fundamental scientific technology,
• I Incorporate the same basic circuit design,
• I Incorporate the same materials,
• Same shelf life
• . Same physical appearance
• I Packaged using the same materials, and
• 1 Manufactured by the same process.

The modifications encompass:

• . Remove strip coding and
• Labeling change due to the modification .

6. Test Principle:

The detection and measurement of glucose in blood is by an electrochemical biosensor

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technology using glucose oxidase.

• 7. Performance Characteristics:
     The FORA V10 Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

A comparison of precision and system accuracy performance demonstrated that the FORA V10 Blood Glucose Monitoring System and the currently marketed FORA V10 Blood Glucose Monitoring System are substantially equivalent, the laboratory tests showed that the device met the requirements of ISO 15197.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA V10 Blood Glucose Monitoring System are equivalent to the predicate device.

• 8. Conclusion:
     Based on the information provided in this submission, the FORA V10 Blood Glucose Monitoring System is substantially equivalent to the predicate FORA V10 Blood Glucose Monitoring System.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

TaiDoc Technology Corporation c/o Ms. Debra Liang Specialist. Regulatory Affairs 6F, No.127, Wugong 2nd Rd. Wugu Township, Taipei County China (Taiwan) 24888

DEC 2 4 2009

Re: K093035

Trade/Device Name: FORA V10 Blood Glucose Monitoring System, Model TD-4244 Regulation Number: 21 CFR $862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: November 24, 2009 Received: December 2, 2009

Dear Ms. Debra Liang:

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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 [phone]. 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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

CA

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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Indications for Use

510(k) Number (if known): K093035

Device Name: FORA V10 Blood Glucose Monitoring System, Model TD-4244

Indications For Use:

The FORA V10 Blood Glucose Monitoring System, Model TD-4244 is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: palm, forearm, upper-arm, calf and 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 FORA V10 Blood Glucose Monitoring System, Model TD-4244 can be used only during steady-state blood glucose conditions.

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

Over-The-Counter Use X (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)

Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety:
510(k) K093035

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