K Number

Device Name

NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254

Manufacturer

TaiDoc Technology Corporation

Date Cleared

2009-12-10

(149 days)

Product Code

NBW CGA SYS

Regulation Number

862.1345

Intended Use

FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A are 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 TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Device Description

FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System consists of Glucose meter, Test Strips, Two levels of Control solution, A commercially available (510(k) cleared) lancing device and sterile Lancets, User Manual, and Storage Pack.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K082482

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components, algorithms, or related technologies.

Therapeutic

No
The device is a blood glucose monitoring system, used to measure glucose levels for diabetes management, not to treat the condition.

Diagnostic

Yes

Explanation: The device is a "Blood Glucose Monitoring System" intended for the "quantitative measurement of glucose" and is an "aid in monitoring the effectiveness of diabetes control program." Even though it explicitly states it is "not intended for the diagnosis of or screening for diabetes mellitus," monitoring and measuring are core functions of diagnostic devices.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as a Glucose meter, Test Strips, Control solution, lancing device, and lancets, indicating it is a system with both hardware and software.

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 involves testing a biological sample (blood) outside of the body to obtain diagnostic information (glucose levels).
Device Description: The system includes components like "Test Strips" and "Control solution", which are typical consumables used in in vitro diagnostic testing.
Performance Studies: The performance studies describe comparing the system's accuracy, which is a key aspect of evaluating an IVD's reliability.

The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood glucose monitoring system clearly fits this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The alternative site testing in the FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Product codes

NBW, CGA

Device Description

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

A comparison of system accuracy performance demonstrated that the FORA TD-4251 //U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A and the currently marketed FORA TD-4251/ URIGHT TD-4252 / URIGHT TD-4254 Blood Glucose Monitoring System are substantially equivalent. A mechanical resistance test showed that the model TD-4253 meet the requirement of EN ISO 15197.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A are equivalent to the predicate device.

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

Not Found

Predicate Device(s)

K082482

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

Section 10. 510(k) Summary

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: _______________________________________________________________________________________________________________________________________________

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: +886-2-6625-8188 #1198 Fax: +886-2-6625-0288 Email: debra.liang@taidoc.com.tw

Date of submission:

1. Device name:
  Proprietary name: FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A

Regulatory information:

Regulation section: 21 CFR 862.1345 Glucose Test System A.
B. Classification: Class II

CGA, Glucose Oxidase, Glucose C. Product Code: NBW, System, Test, Blood Glucose, Over The Counter Chemistry (75) D. Panel:

1. Intended Use:
  FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254

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DEC 1 0 2009

No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A are 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.

1. Device Description:
  FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System consists of Glucose meter, Test Strips, Two levels of Control solution, A commercially available (510(k) cleared) lancing device and sterile Lancets, User Manual, and Storage Pack.
1. Substantial Equivalance Information:
  Predicate device name: A. FORA TD-4251/ URIGHT TD-4252 / URIGHT TD-4254 Blood Glucose Monitoring System

Predicate K number: K082482 B.

Comparison with predicate: C.

The modified FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A have the following similarities to the predicate device:

same operating principle, ■
same fundamental scientific technology, ■
incorporate the same basic circuit design, ■
미 incorporate the same materials,
same shelf life
packaged using the same materials, and ■
Manufactured by the same process.

The modifications encompass:

A modification in the software of the glucose meter I
Modification in the physical appearance ■
Labeling change due to the software modification .

6. Test Principle:

The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase.

1. Performance Characteristics:
  The FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring Systems have the same performance characteristics as the predicate device.

1. Conclusion:
  Based on the information provided in this submission, the FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A are substantially equivalent to the predicate FORA TD-4251/ URIGHT TD-4252 / URIGHT TD-4254 Blood Glucose Monitoring System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

DEC 1 0 2009

K092099 Re:

Trade/Device Name: FORA TD-4251/U-RIGHT TD-4252/ U-RIGHT TD-4253/ U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: November 11, 2009 Received: November 12, 2009

Dear Ms. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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.

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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

Section 7 Indications for Use

Indications for Use

K092099 510(k) Number:

Device Name: FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A

Indications for Use:

Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use X (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)

Division Sign-off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 8092090 510(k)

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