(21 days)
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No
The provided text describes a standard blood glucose and blood pressure measurement system and does not mention any AI or ML capabilities.
No
The device is described as a measurement system for in vitro diagnostic use, intended for monitoring and aiding in diabetes control programs and measuring blood pressure and pulse rate. It does not mention treating, preventing, or mitigating disease, which are characteristics of a therapeutic device.
Yes
The text explicitly states, "These Clever Chek TD-3215"M / Dr. T TD-3216"M Blood Glucose and Blood Pressure Measurement Systems are intended for in vitro diagnostic use."
No
The device description is not available, but the intended use clearly describes a "Blood Glucose and Blood Pressure Measurement Systems" that uses a "Blood Glucose" meter and a "technique in which an inflatable cuff is wrapped around the wrist" for blood pressure. These are hardware components, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"These Clever Chek TD-3215"M / Dr. T TD-3216"M Blood Glucose and Blood Pressure Measurement Systems are intended for in vitro diagnostic use."
This statement directly identifies the device as an IVD. The subsequent description of measuring glucose in capillary whole blood further supports this classification, as this is a common application for in vitro diagnostics.
N/A
Intended Use / Indications for Use
These Clever Chek TD-3215"M / Dr. T TD-3216"M Blood Glucose and Blood Pressure Measurement Systems are intended for in vitro diagnostic use.
These systems are intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates.
These systems are also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".
Product codes
NBW
Device Description
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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
fingertip, wrist
Indicated Patient Age Range
Not intended for use on neonates, adult individual over age 16
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
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/12 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three curved lines that resemble a stylized representation of the human form.
Public Health Service
Image /page/0/Picture/3 description: The image shows the date August 8, 2005. The month is represented by the abbreviation AUG. The day is represented by the number 8, and the year is represented by the number 2005. The date is written in a simple, sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sophia, Shu-Mei Wu, Ph.D. TaiDoc Technology Corporation 4F, No. 88, Sec. 1, Kwang-Fu Rd., San-Chung Taipei County 241 Taiwan
Re: K051936
Trade/Device Name: Clever Chek TD-3215™ Dr. T TD-3216TM Blood Glucose and Blood Pressure Measurement System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 14, 2005 Received: July 18, 2005
Dear Dr. Wu:
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).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin managing of substantial equivalence of your device to a legally premarket notification: "The Pull in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, IT you desire specific information acountising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the VITO Dagnostic Do Moo Danding by reference to premarket notification" (21 CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the I ou may outlict general monitations on Jour Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Attachment 2
Indications for Use
510(k) Number:
Device Name: Clever Chek TD-3215™ I Dr. T TD-3216™ Blood Glucose and Blood Pressure Measurement System
Indications for Use:
These Clever Chek TD-3215"M / Dr. T TD-3216"M Blood Glucose and Blood Pressure Measurement Systems are intended for in vitro diagnostic use.
These systems are intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates.
These systems are also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
oncurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD)
Office of In Vitro Diagnostic Deidee FEvaluation and Safet A2 - 1
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5510(k) K051936