(112 days)
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No
The document describes a standard blood glucose monitoring system and contains no mention of AI, ML, or related concepts.
No
The device is a blood glucose monitoring system, which measures glucose levels. It is used to monitor the effectiveness of a diabetes control program, not to directly treat or cure a disease.
No
The text explicitly states: "It is not intended for the diagnosis of or screening for diabetes mellitus". While it aids in monitoring, it's not for initial diagnosis.
No
The device is described as a "Blood Glucose Monitoring System" which measures glucose in blood. This inherently requires hardware components (like a meter and test strips) to interact with the biological sample. The summary does not mention any software-only functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in fresh capillary whole blood". This involves testing a biological sample (blood) outside of the body to gain information about a person's health status (glucose levels related to diabetes).
- Nature of the Test: Measuring glucose in blood is a classic example of an in vitro diagnostic test.
The other information provided, such as the anatomical sites, intended users, and limitations (not for diagnosis or screening, not for neonates), further clarifies the specific application of this IVD.
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Intended Use / Indications for Use
The Achtung TD-4207 no code/Clever Chek TD-4209 one-code/Clever Chek TD-4222 no code/Clever Chek TD-4225 no code/Clever Chek TD-4226 one-code 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 above systems can be used only during steady-state blood glucose conditions.
Product codes
NBW, CGA
Device Description
Achtung TD-4207, Clever Check TD-4209, Clever Chek TD-4222, Clever Chek TD-4225, Clever Chek TD-4226 Blood Glucose Monitoring Systems
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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Image /page/0/Picture/1 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 stripes forming its wing and body. The eagle faces to the right. Encircling the eagle are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Taidoc Technology Corporation c/o Yuhua Chen 6F, No. 127, Wugong 2nd Rd. Taipei County, China (Taiwan) 248
APR - 2 2008
Re: K073494
Trade/Device Name: ACHTUNG TD-4207, Clever Check TD-4209, Clever Chek TD-4222, Clever Chek TD-4225, Clever Chek TD-4226 Blood Glucose Monitoring Systems Regulation Number: 21 CFR8862,1345
Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: March 19, 2008 Received: March 20, 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. Ilsting 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.
Yean 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
2
Attachment 2
Indications for Use
510(k) Number:
Device Name: Achtung TD-4207 no code, Clever Chek TD-4209 one-code, Clever Chek TD-4222 no code, Clever Chek TD-4225 no code, Clever Chek TD-4226 one-code Blood Glucose Monitoring System
Indications for Use:
The Achtung TD-4207 no code/Clever Chek TD-4209 one-code/Clever Chek TD-4222 no code/Clever Chek TD-4225 no code/Clever Chek TD-4226 one-code 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 above systems can be used only during steady-state blood glucose conditions.
Prescription Use _ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Sign
e of In Vitro Diagnostic L muation and Safely
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