(62 days)
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No
The summary describes a standard blood glucose monitoring system with a voice feature for visually impaired users. There is no mention of AI or ML in the intended use, device description, or any other section.
No
This device is for monitoring glucose levels, which aids in managing diabetes, but it does not directly treat or cure the condition.
No
The "Intended Use / Indications for Use" section explicitly states: "It is not intended for the diagnosis of or screening for diabetes mellitus".
No
The device description explicitly states "CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System," which is a physical system for measuring blood glucose. While it has a speaking functionality (software component), the core function relies on hardware for blood glucose measurement.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device 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 information about a person's health status (glucose levels).
- Definition of IVD: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device fits that definition perfectly.
The fact that it's used to monitor glucose levels in blood samples makes it an IVD.
N/A
Intended Use / Indications for Use
The CLEVER CHEK Auto-Code Voice 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 Auto-Code Voice Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
Product codes
NBW, CGA, JJX
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)
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Reference Device(s)
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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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 8 2008
TaiDoc Technology Corp. c/o Yuhua Chen Specialist Regulatory Affairs 6F, No. 127, Wugong 2nd Road Wugu Township, Taipei County China (Taiwan) 248
Re: K081144
Trade Name: CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: June 4, 2008 Received: June 5. 2008
Dear Yuhua Chen:
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, perroits 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 Officer 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.
Jean 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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Indication for Use
510(k) Number:
Device Name: CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System
Indication For Use:
The CLEVER CHEK Auto-Code Voice 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 Auto-Code Voice Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
Prescription Use (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)
Carol C. Benson
Division Siañ-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081144