(162 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No
The device is intended for the quantitative measurement of glucose to aid in monitoring the effectiveness of a diabetes control program, not for therapeutic intervention.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not intended for the diagnosis of or screening for diabetes mellitus." It is intended as an aid in monitoring the effectiveness of diabetes control programs.
No
The device description explicitly lists hardware components such as a Glucose Meter, Test Strips, Control solution, lancing device, and sterile Lancets.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in fresh capillary whole blood". This involves testing a biological sample (blood) in vitro (outside the body) to obtain diagnostic information (glucose levels).
- Device Description: The components listed, such as the Glucose Meter, Test Strips, and Control solution, are typical components of an IVD system used for analyzing biological samples.
- Purpose: The purpose is to aid in "monitoring the effectiveness of diabetes control program," which is a diagnostic purpose related to managing a disease.
While it's not intended for the diagnosis or screening of diabetes, the act of measuring glucose in a blood sample in vitro for monitoring purposes falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 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 U-RIGHT TD-4238 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW
Device Description
The kit of U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring Systems consist of Glucose Meter, Test Strips, Control solution, A commercially available (510(k) cleared) 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
fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the 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)
Software verification and validation testing confirmed that the performance, safety and effectiveness of the U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System are equivalent to the predicate device.
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.
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
Section 11. 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:
-
- 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 #1196 Fax: +886-2-6625-0288 Email: debra.liang@taidoc.com.tw
- Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
Date of submission: 09/17/2009
-
- Device name:
Proprietary name: U-RIGHT TD-4238 Blood Glucose Monitoring System and U-RIGHT TD-4246 Blood Glucose Monitoring System
- Device name:
Regulatory information:
- A. Regulation section: 21 CFR 862.1345 Glucose Test System
- B. Classification: Class II
- CGA, Glucose Oxidase, Glucose Product Code: C. . NBW, System, Test, Blood Glucose, Over The Counter D. Panel: Chemistry (75)
1
3. Intended Use:
The U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 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.
4. Device Description:
The kit of U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring Systems consist of Glucose Meter, Test Strips, Control solution, A commercially available (510(k) cleared) lancing device and sterile Lancets, User Manual, and Storage Pack.
5. Substantial Equivalence Information:
Predicate device name: A. FORA G30/TD-4241 Blood Glucose Monitoring System
Predicate K number: K090187 B.
Comparison with predicate: ﺯ
The modified U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System have the following similarities to the predicate device:
- same operating principle,
- . same fundamental scientific technology,
- incorporate the same basic circuit design,
- incorporate the same materials,
- . same shelf life
- li packaged using the same materials, and
- Manufactured by the same process. I
2
The modifications encompass:
- . A modification in the software of the glucose meter
- Modification in the physical appearance ■
- Labeling change due to the software modification 용
-
- Test Principle:
The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase.
-
- Performance Characteristics:
U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System have the same performance characteristics as the predicate device.
- Performance Characteristics:
A comparison of system accuracy performance demonstrated that the U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System and the currently marketed FORA G30/TD-4241 Blood Glucose Monitoring System are substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System are equivalent to the predicate device.
-
- Conclusion:
Based on the information provided in this submission, the U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System are substantially equivalent to the predicate FORA G30/TD-4241 Blood Glucose Monitoring System.
- Conclusion:
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
MAR 0 2 2010
Taidoc Technology Corporation c/o Ms. Debra Liang Regulatory Affairs Specialist 6F, 127, Wugong 2nd RD Wugu Township Taipei County, China (Taiwan) 248
Re: K092902
Trade Name: U-Right TD-4238 Blood Glucose Monitoring System and U-Right TD-4246 Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW, CGA Dated: February 4, 2010 Received: February 4, 2010
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); medical device reporting (reporting of medical device-related adverse events) (21
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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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
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
5
Section 8.1 Indications for Use (TD-4238)
Indications for Use
510(k) Number:
Device Name: U-RIGHT TD-4238 Blood Glucose Monitoring System
Indications for Use:
The U-RIGHT TD-4238 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 U-RIGHT TD-4238 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
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)
Signature of Issuer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Ko92902
Page 1 of
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Section 8.2 Indications for Use (TD-4246)
Indications for Use
510(k) Number:
Device Name: U-RIGHT TD-4246 Blood Glucose Monitoring System
Indications for Use:
The U-RIGHT TD-4246 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 U-RIGHT TD-4246 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
And/Or
Prescription Use (21 CFR Part 801 Subpart D)
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 (OVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 10 0 0 2 2 0 2
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