(144 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 for monitoring glucose levels, not for treating or providing therapy for diabetes.
No.
The "Intended Use" section explicitly states that the device "is not intended for the diagnosis of or screening for diabetes mellitus".
No
The device description explicitly states the kit consists of a meter with blood glucose measurement function, test strips, and control solutions, which are all hardware components.
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 from the finger." This involves testing a biological sample (blood) outside of the body to provide information about a person's health status (glucose levels related to diabetes).
- Device Description: The description mentions "test strips and control solutions," which are common components of IVD systems used for chemical or biological analysis of samples.
- Regulatory Context: The presence of predicate devices with K numbers (indicating FDA clearance) further supports its classification as a medical device, and given its function, specifically an IVD.
The definition of an IVD generally involves devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device clearly fits that description for monitoring blood glucose levels.
N/A
Intended Use / Indications for Use
TD-4277 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. 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.
Professionals may use the test strips to test capillary and venous blood samples, but lay user may not test venous blood samples
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX
Device Description
The kit of TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277 consists of: the meter with blood glucose measurement function, test strips and control solutions. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
The laboratory and clinical studies for the performance of TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277 demonstrated that the performance of this system meets its intended use.
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.
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3. 510(k) Summary
JUN 2 8 2010
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: K100322
- 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 preparation: February 1, 2010
-
- Device name:
Proprietary name: TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277
- Device name:
Regulatory information:
| A. | Regulation section: 21 CFR § 862.1345, Glucose Test System
21CFR 862.1660 Quality control material (assayed and
unassayed). |
|----|-----------------------------------------------------------------------------------------------------------------------------------|
| B. | Classification: Class II (Glucose Test System)
Class 1 (Quality control material (assayed and
unassayed) (reserved) |
| C. | Product Code: NBW, System, Test, Blood Glucose, Over The Counter
LFR, glucose dehydrogenase, glucose |
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JJX Single (Specified) Analyte Controls (Assayed and Unassayed)
Panel: 75, Clinical Chemistry - Glucose Test System
3. Intended Use:
TD-4277 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. 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.
Professionals may use the test strips to test capillary and venous blood samples, but lay user may not test venous blood samples
-
- Device Description:
The kit of TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277 consists of: the meter with blood glucose measurement function, test strips and control solutions. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.
- Device Description:
-
- Substantial Equivalence Information:
- A. Predicate device name:
TaiDoc Pro I Glucose Test Strip, K082169
FORA G30 blood glucose monitoring system, K090187
B. Comparison with predicate:
The TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277 has the equivalent technological characteristics and the similar intended use as the predicate devices.
-
- Test Principle:
For blood glucose, the detection and measurement is by an electrochemical biosensor technology using glucose dehydrogenase.
- Test Principle:
-
- Performance Characteristics:
The laboratory and clinical studies for the performance of TD-4277 BLOOD
- Performance Characteristics:
2
GLUCOSE MONITORING SYSTEM MODEL TD-4277 demonstrated that the performance of this system meets its intended use.
-
- Conclusion:
Based on the information provided in this submission, the TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277 is substantially equivalent to the predicate devices.
- Conclusion:
3
Image /page/3/Picture/0 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line.
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Taidoc Technology Corporation c/o Debra Liang Regulatory Affairs Specialist 6f, No. 127, Wugong 2nd Rd, Wugu Township Taipei County. 248 TW - CHINA (TAIWAN)
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
JUN 2 8 2010
Re: K100322
Trade/Device Name: TD-4277 Blood Glucose Monitoring System. Model 4277 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, LFR, JJX Dated: June 25, 2010 Received: June 28, 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 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 (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
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Attachment G.
Indications for Use
510(k) Number: K100322
Device Name: TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4277
Indications for Use:
TD-4277 Blood Glucose Monitoring System, Model TD-4277 is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. It is intended for use by healthcare professionals and people with diabetes mellius 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.
Professionals may use the test strips to test capillary and venous blood samples, but lay user may not test venous blood samples.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (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 Device Evaluation and Safety (OVD)
Chris
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K/00322
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