(48 days)
Not Found
No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for active treatment or therapy.
Yes
The device is an "in vitro diagnostic use" device, as stated in the "Intended Use / Indications for Use" section. It measures glucose levels to aid in monitoring diabetes control, which is a diagnostic function. However, it explicitly states it is "not intended for the diagnosis of or screening for diabetes mellitus," indicating it does not diagnose the disease itself but provides measurements that assist in managing a pre-existing condition.
No
The device description explicitly states the system consists of a meter, test strips, and control solutions, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states:
- "The TD-4257 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)..." (for the single use device)
- "The TD-4257 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use)..." (for the multiple patient use device)
This clearly indicates that the device is designed to be used outside the body to examine specimens (blood) from the human body for the purpose of providing information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The TD-4257 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared.
The TD-4257 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. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates.
The TD-4257 Blood Glucose Test Strips are for use with the TD-4257 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
The TD-4257 Multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary, venous and neonatal whole blood samples. The TD-4257 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple patient use in professional healthcare settings as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus.
Professionals may test with capillary, venous and neonatal whole blood. Capillary samples may be drawn from the fingertip, and in the case of neonates, from the heel.
The system is only used with single-use, auto-disabling lancing devices.
The TD-4257 Multi Blood Glucose Test Strips are for use with the TD-4257 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.
Product codes
LFR, NBW
Device Description
The system consists 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger (for single-person use), Fingertip, Heel (for neonates) (for multiple-patient use)
Indicated Patient Age Range
Not intended for use on neonates (for single-person use). Neonatal (for multiple-patient use).
Intended User / Care Setting
Single person with diabetes at home (for single-person use). Professionals in professional healthcare settings (for multiple-patient use).
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
TD-4257 Blood Glucose Monitoring System/TD-4257 Multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device.
A comparison of system accuracy performance demonstrated that the TD-4257 Blood Glucose Monitoring System/TD-4257 Multi Blood Glucose Monitoring System and the TD-4239 Blood Glucose Monitoring System/TD-4239 Multi Blood Glucose Monitoring System are substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the TD-4257 Blood Glucose Monitoring System /TD-4257 Multi Blood Glucose Monitoring System are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K112963
NOV 222 2011
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 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan
Correspondent: Teling Hsu Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1176 Fax: +886-2-6625-0288 Email: teling.hsu(@taidoc.com.tw
- Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan
Prepared date: September 30, 2011
-
- Device name:
Proprietary name: TD-4257 Blood Glucose Monitoring System and TD-4257 Multi Blood Glucose Monitoring System
- Device name:
Regulatory information:
- Regulation section: 21 CFR 862.1345 Glucose Test System A.
- B. Classification: Class II
- C. Product Code: LFR, Glucose Dehydrogenase, Glucose NBW, System, Test, Blood Glucose, Over The Counter D. Panel: Clinical Chemistry (75)
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3. Intended Use:
For single use device
The TD-4257 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared.
The TD-4257 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. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates.
The TD-4257 Blood Glucose Test Strips are for use with the TD-4257 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
For multiple patient use device
The TD-4257 Multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary, venous and neonatal whole blood samples. The TD-4257 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple patient use in professional healthcare settings as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus.
Professionals may test with capillary, venous and neonatal whole blood. Capillary samples may be drawn from the fingertip, and in the case of neonates, from the heel.
The system is only used with single-use, auto-disabling lancing devices.
The TD-4257 Multi Blood Glucose Test Strips are for use with the TD-4257 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.
4. Device Description:
The system consists 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.
-
- Substantial Equivalence Information:
2
- Predicate device name: TD-4239 Blood Glucose Monitoring System and A. TD-4239 Multi Blood Glucose Monitoring System
- Predicate K number: K101635 B.
- C. Comparison with predicate:
The modified TD-4257 Blood Glucose Monitoring System and TD-4257 Multi Blood Glucose Monitoring System have the following similarities to the predicate device:
- 트 same operating principle.
- 8 same fundamental scientific technology.
- I incorporate the same basic circuit design.
- . incorporate the same materials.
- B same shelf life
- 트 packaged using the same materials, and
- manufactured by the same process. .
The modifications encompass:
- 트 Modification in the physical appearance
- . Minor software modifications of the glucose meter
- . Change of the data transmission method from RS-232 to Bluetooth
- . Labeling change due to the above modifications
-
- Test Principle:
The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose dehydrogenase.
-
- Performance Characteristics:
TD-4257 Blood Glucose Monitoring System/TD-4257 Multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device.
- Performance Characteristics:
A comparison of system accuracy performance demonstrated that the TD-4257 Blood Glucose Monitoring System/TD-4257 Multi Blood Glucose Monitoring System and the TD-4239 Blood Glucose Monitoring System/TD-4239 Multi Blood Glucose Monitoring System are substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the TD-4257 Blood Glucose Monitoring System /TD-4257 Multi Blood Glucose Monitoring System are equivalent to the predicate device.
3
8. Conclusion:
。
『
Based on the information provided in this submission, the TD-4257 Blood Glucose Monitoring System and TD-4257 Multi Blood Glucose Monitoring System are substantially equivalent to the predicate TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System.
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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Image /page/4/Picture/4 description: The image shows the text "NOV 2 2 -2011". The text appears to be a date, with the month being November, the day being the 2nd, and the year being 2011. The text is in a bold font and is slightly blurry. The background of the image is white.
Taidoc Technology Corporation c/o Teling Hsu 3f, 5f, No.127 Wugong 2nd Rd, Wugu District New Taipei City, Taiwan 24888
K112963 Re:
TD-4257 Blood Glucose Monitoring System Trade name: TD-4257 Multi Blood Glucose Monitoring System Regulation Number: 21CFR §862.1345 Glucose test system Regulation Name: Class II Regulatory Class: NBW, LFR Product Codes: Dated: September 30, 2011 Received: October 5, 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 with and proval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls actions 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 (1 writ), it may ou device can be found in Title 21, Code of Federal Regulations (CFR), Parts attooting your 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 not invan uts 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 I vard 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 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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/Medical Devices/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,
signature
Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Section 8.
Indications for Use
510(k) Number (if known): 属//2963
Device Name: TD-4257 Blood Glucose Monitoring System, model TD-4257
Indications for Use:
The TD-4257 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared.
The TD-4257 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. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates.
The TD-4257 Blood Glucose Test Strips are for use with the TD-4257 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
Prescription Use Over-The-Counter Use X 21 CFR 801 Subpart D) (21 CFR 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 (OIVD)
CRS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_K112963
7
Indications for Use
510(k) Number (if known):
Device Name: TD-4257 Multi Blood Glucose Monitoring System, model TD-4257
Indications for Use:
The TD-4257 Multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary, venous and neonatal whole blood samples. The TD-4257 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple patient use in professional healthcare settings as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus.
Professionals may test with capillary, venous and neonatal whole blood. Capillary samples may be drawn from the fingertip, and in the case of neonates, from the heel.
The system is only used with single-use, auto-disabling lancing devices.
The TD-4257 Multi Blood Glucose Test Strips are for use with the TD-4257 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use X (21 CFR 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 (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K-11296