(28 days)
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No
The 510(k) summary describes a standard blood glucose meter and does not mention any AI or ML capabilities.
No
The device is a diagnostic tool used for monitoring blood glucose levels, which aids in managing diabetes, rather than directly treating the condition.
No
The extract states, "It is not intended for the diagnosis of or screening for diabetes mellitus."
No
The device is a blood glucose test system, which inherently involves hardware (test strips, meter) for measuring glucose in whole blood. The description focuses on the system's intended use and does not indicate it is solely software.
Yes, based on the provided information, the Clever Chek TD-4225 Blood Glucose Test System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in whole blood taken from the finger." 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 sections, while providing useful context about the device's use and limitations, don't contradict its classification as an IVD. The lack of information on image processing, AI, training/test sets, and performance studies is common for simpler IVD devices that rely on established electrochemical or enzymatic methods for measurement, rather than complex algorithms or imaging.
N/A
Intended Use / Indications for Use
The Clever Chek TD-4225 Blood Glucose Test System is intended for use in the quantitative measurement of glucose in whole blood taken 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.
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
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Indicated Patient Age Range
It is 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 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.
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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 consists of a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
AUG 5 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sophia, Shu-Mei Wu, Ph.D. Project Manager TaiDoc Technology Corporation 4F, No. 88, Sec. 1, Kwang-Fu Rd. San-Chung Taipei County 241 Taiwan
Re: K051854
Trade/Device Name: Clever Chek TD-4225 Glucose Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 6, 2005 Received: July 8, 2005
Dear Dr. Shu-Mei 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) This letter will anow you to begin marketing your antial equivalence of your device to a legally premarket nonfeadon. - The PDF interlassification 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 you destre specific into into in advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the Pitto Diagnostic Do Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may other general international and 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. Benson
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
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Indications for Use
510(k) Number: K051854
Device Name: Clever Chek TD-4225 Blood Glucose Test System
Indications For Use:
The Clever Chek TD-4225 Blood Glucose Test System is intended for use in the quantitative measurement of glucose in whole blood taken 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051854