(447 days)
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No
The document describes a standard electrochemical biosensor for glucose measurement and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is described as a "Blood Glucose Monitoring System" intended for quantitative measurement of glucose to aid in monitoring the effectiveness of diabetes control. It is an in vitro diagnostic device, not a therapeutic device.
No
The text explicitly states that the device "is not intended for the diagnosis of or screening for diabetes mellitus." It is intended as an "aid to monitor the effectiveness of diabetes control."
No
The device description explicitly states that the system consists of a meter, test strips, and control solutions, which are hardware components.
Yes, both the TD-4239 Blood Glucose Monitoring System and the TD-4239 Multi Blood Glucose Monitoring System are explicitly stated to be IVD (In Vitro Diagnostic) devices in their intended use descriptions.
The text clearly states:
- "The TD-4239 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)..."
- "The TD-4239 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use)..."
This confirms their classification as IVD devices.
N/A
Intended Use / Indications for Use
For single use device
The TD-4239 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-4239 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-4239 Blood Glucose Test Strips are for use with the TD-4239 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
For multiple patient use device
The TD-4239 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-4239 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 It is not intended for the diagnosis of or screening for diabetes mellitus. control.
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-4239 Multi Blood Glucose Test Strips are for use with the TD-4239 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.
Product codes (comma separated list FDA assigned to the subject device)
nbw, LFR
Device Description
The TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System consist 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. Use only TD-4239 and TD-4239 Multi test strips for the TD-4239 and TD-4239 Multi Blood Glucose Monitoring Systems, and use with the control solutions that has been tested and validated with this system to perform quality checks.
The blood glucose detection method and measurement is by an electrochemical biosensor technology using FAD-dependent glucose dehydrogenase (FAD-GDH).
The two blood glucose systems have the same technical components (same meter and test strips) and therefore the same performance data.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
finger, fingertip, heel
Indicated Patient Age Range
Not intended to be used on neonates for the single-use system. Neonatal whole blood samples can be used with the multiple patient use device.
Intended User / Care Setting
TD-4239 Blood Glucose Monitoring System: a single person, self testing, at home.
TD-4239 Multi Blood Glucose Monitoring System: multiple patient use, professional healthcare settings, professionals.
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)
The laboratory and clinical studies for the system performance of TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System demonstrate the meter and test strip works well as a system.
Software verification and validation tests confirmed that the performance, safety and effectiveness of the TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
101635
AUG 3 1 2011
510 (k) Summary
- Submitter Information Company name Contact person Address
Phone FAX E-mail Date Prepared
- Name of Device Trade/Proprietary Name
Common Names Product Code Classification Panel Regulations
- Predicate Device Trade/Proprietary Name:
Common/Usual Name: Submitter 510 (k) Number
TaiDoc Technology Corporation Teling Hsu 3F, 5F, No. 127, Wugong 2nd Rd., Wugu Township, Taipei County, 24888, Taiwan (+886-2) 6625-8188 ext.1176 (+886-2) 6625-0288 teling.hsu@taidoc.com.tw June 7th, 2010
TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System Blood glucose test system nbw, LFR Clinical Chemistry (75) Class II 21 CFR 862.1345
FORA G31 Blood Glucose Monitoring System (Model TD-4256) Blood qlucose test system TaiDoc Technology Corporation K094005
1
4. Device Description
The TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System consist 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. Use only TD-4239 and TD-4239 Multi test strips for the TD-4239 and TD-4239 Multi Blood Glucose Monitoring Systems, and use with the control solutions that has been tested and validated with this system to perform quality checks.
The blood glucose detection method and measurement is by an electrochemical biosensor technology using FAD-dependent glucose dehydrogenase (FAD-GDH).
The two blood glucose systems have the same technical components (same meter and test strips) and therefore the same performance data.
5. Intended Use
For single use device
The TD-4239 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-4239 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-4239 Blood Glucose Test Strips are for use with the TD-4239 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
For multiple patient use device
The TD-4239 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-4239 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 It is not intended for the diagnosis of or screening for diabetes mellitus. control.
2
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-4239 Multi Blood Glucose Test Strips are for use with the TD-4239 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.
6. Comparison to Predicate Device
The TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System have the same operating principle and same fundamental scientific technology as FORA G31 Blood Glucose Monitoring System (K094005). Modifications include test strip change, meter outer casing design, and software modifications. Accuracy study and software validation were performed to evaluate the meter performance. Results show that both devices are substantially equivalent to the predicate device K094005.
7. Performance Studies
The laboratory and clinical studies for the system performance of TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System demonstrate the meter and test strip works well as a system.
Software verification and validation tests confirmed that the performance, safety and effectiveness of the TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System are equivalent to the predicate device.
8. Conclusion
The TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System demonstrate satisfactory performance. The TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System are therefore substantially equivalent to the predicate device.
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Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Image /page/3/Picture/4 description: The image shows a date, "AUG 3 1 2011", in bold, sans-serif font. The letters and numbers are closely spaced together. The date appears to be stamped or printed, as the ink is slightly uneven.
Taidoc Technology Corporation c/o Teling Hsu 3f,5f, No.127 Wugong 2nd Rd, Wugu Township Taipei County Taiwan 24888
K101635 Re: TD-4239 Blood Glucose Monitoring System Trade name: I D-4239 Blood Glacose Monitoring System 21CFR §862.1345 Regulation Number: Glucose test system Regulation Name: Class II Regulatory Class: NBW, LFR Product Codes: Dated: August 25, 2011 Received: August 29, 2011
Dear Ms. Hsu,
We have reviewed your Section 510(k) premarket notification of intent to market the We have reviewed your Section > IU(K) prematics is substantially equivalent (for
device referenced above and have determined the levice is substanticate devices device referenced above and have determined the covles marketed predicate devices
the indications for use stated in the enclosure) to legally marketed predicate of the the indications for use stated in the enclosures to rogans, the enactment date of the enactment date of the marketed in interstate commerce problem that have been reclassified in accordance
Medical Device Amendments, or to devices that have been reclassified in accordance Medical Device Amendments, or to devices mar necessary that do not require
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) the with the provisions of the Federal Pood, Drug, and Cosmons (Cherefore, market the the
approval of a premarket approval application (PMA). You may, the enerals approval of a premarket approval approvisions of the Act. The general controls
device, subject to the general controls provisions of the Act. The general controls device, subject to the general controls for annual registration, listing of devices,
provisions of the Act include requirements for annual registrating and provisions of the Act include requirements for annual regent and provided in
good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
lf your device is classified (see above) into either class II (Special Controls) or class III
n and the success of the blitional controls. Existing major regulations If your device is classitied (see above) into enner olso regulations)
(PMA), it may be subject to such additional controls. Existing major regulations (CFF (PMA), it may be subject to such additional controls. Existing major elegal and Crising your devices (CFR), Parts
affecting your device De tound in Title 21, Code of Federal affecting your device can be found in Title 21, Code of Pearline announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does
and the contract and and tempiration that your device complies with other Please be advised that FDA's issuance of a substantial oqur device complies with other
not mean that FDA has made a detectations administered by other not mean that FDA has made a determination that your dories administered by other requirements of the Act of any Federal statules and regulirements, including, but not
Federal agencies. You must comply with all the Act's requirements, including (21 CFR Pa Federal agencies. You must comply with an the rice is not in the Parts 801 and limited to: registration and listing (21 CPK Fall of medical device-related adverse events) (21
809); medical device reporting (reporting of medical device-related adverse ev 809); medical device reporting (reporting of medical as not of the requirements as set forth in the quality
CFR 803); and good manufacturing practice requirements as set fort CFR 603), and Bookstion (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 Viro 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 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/MedicalDevicesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Attachment C4
Indications for Use
510(k) Number: K101635
Device Name: TD-4239 Blood Glucose Monitoring System
Indications for Use:
The TD-4239 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-4239 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-4239 Blood Glucose Test Strips are for use with the TD-4239 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
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 (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety KI 0163 510(k) =
Page 1 of 2
i
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Indications for Use
510(k) Number: K101635
Device Name: TD-4239 Multi Blood Glucose Monitoring System
Indications for Use:
The TD-4239 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-4239 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-4239 Multi Blood Glucose Test Strips are for use with the TD-4239 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.
Prescription Use _ X (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 Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_ j