(23 days)
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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 described as a "Blood Glucose Monitoring System" and is used for the "quantitative measurement of glucose." Its purpose is to aid in "monitoring the effectiveness of diabetes control program," not to provide therapy.
Yes
The device is described as aiding in "monitoring the effectiveness of diabetes control program," which implies assessing the state of a condition rather than diagnosing it. However, the explicitly stated "It is not intended for the diagnosis of or screening for diabetes mellitus" clearly indicates it is not a diagnostic device for initial diagnosis. Devices that aid in monitoring or managing a disease, even if not for initial diagnosis, are considered diagnostic tools within the broader sense of diagnosing or assessing a patient's health status.
No
The device is described as a "Blood Glucose Monitoring System" which typically involves hardware (a meter and test strips) to measure glucose. The summary does not mention it being software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "quantitative measurement of glucose in fresh capillary whole blood". This involves testing a biological sample (blood) outside of the body to obtain diagnostic information (glucose levels).
- Nature of the Test: Measuring glucose in blood is a classic example of an in vitro diagnostic test.
The other information provided further supports this:
- Anatomical Site: While the blood is taken from the body, the measurement itself happens in vitro (outside the body) using the device and test strips.
- Intended User/Care Setting: The use by healthcare professionals and people with diabetes at home for monitoring diabetes control aligns with the typical use of IVD devices for managing chronic conditions.
The fact that it's "not intended for the diagnosis of or screening for diabetes mellitus" doesn't negate its IVD status. Many IVDs are used for monitoring or managing existing conditions rather than initial diagnosis.
N/A
Intended Use / Indications for Use
The Clever Chek TD-4230/ SureChek 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 Clever Chek TD-4230/ SureChek Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Product codes
NBW, CGA
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
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
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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)
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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.
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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
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
TaiDoc Technology Corporation 4F, 88, SEC. 1, Kwang Fu Road San Chung, Taipei Taiwan, 241 ATTN: Erica Li
MAR 1 5 2007
Re: K070472
Trade/Device Name: Clever Chek TD-4230 Blood Glucose Monitoring System SureChek Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Code: NBW, CGA Dated: February 16, 2007 Received: February 20, 2007
Dear Ms. Li:
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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. 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 2
Indications for Use
510(k) Number:
Clever Chek TD-4230 Blood Glucose Monitoring System Device Name: SureChek Blood Glucose Monitoring System Indications for Use:
The Clever Chek TD-4230/ SureChek 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 Clever Chek TD-4230/ SureChek Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Prescription Use AND/OR -Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (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 Devices (OIVD)
Carol C Benner
Sign-Off
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ිffice of In Vitro Diagnostic Device Evaluation and Safety