(112 days)
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.
Not Found
This looks like a 510(k) summary for a blood glucose monitoring system. To answer your questions, I need to find the specific study details that demonstrate the device meets its acceptance criteria. However, the provided text does not contain the detailed study information such as acceptance criteria tables, sample sizes, ground truth establishment, or specific study designs (MRMC, standalone).
The document is primarily a notification letter from the FDA confirming substantial equivalence to predicate devices and an "Indications for Use" statement. It mentions that the FDA "reviewed your Section 510(k) premarket notification" but does not elaborate on the contents of that notification beyond the "Indications for Use."
Therefore, based solely on the provided text, I can answer some parts with "Not provided" or explain why the information isn't present:
Here's an analysis of what information is available and what is not:
1. A table of acceptance criteria and the reported device performance
- Not Provided. This document does not include any performance data or a table of acceptance criteria for accuracy (e.g., ISO 15197 standards for blood glucose meters).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Provided. The document does not mention any sample sizes for test sets, data origin, or whether studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Provided. For blood glucose meters, the "ground truth" is typically established by a laboratory reference method (e.g., YSI analyzer) rather than expert consensus on images. The document does not specify how ground truth was established, nor does it mention any experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. Adjudication methods like 2+1 or 3+1 are typically used in image-based diagnostic studies involving human readers. This is a blood glucose monitoring system, and its performance is assessed against a referencemethod, not by expert adjudication of interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. MRMC studies are specific to diagnostic imaging and AI (Artificial Intelligence) assistance for human readers. This device is a blood glucose monitor, not an AI-powered diagnostic imaging tool, and therefore MRMC studies are not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, implicitly. Blood glucose meters are inherently "standalone" devices (algorithm only) in the sense that they provide a numerical reading directly without human interpretation in the loop. However, the document does not contain explicit details of such standalone testing. The performance of such a device is typically evaluated against a reference laboratory method for accuracy and precision.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Likely a laboratory reference method, but not explicitly stated. For blood glucose meters, the ground truth is almost universally established using a highly accurate laboratory reference instrument (e.g., YSI glucose analyzer) to measure glucose concentration in blood samples. The document does not explicitly state this, but it is the standard for these devices.
8. The sample size for the training set
- Not Applicable/Not Provided. Blood glucose meters typically do not use "training sets" in the same way machine learning algorithms do. Their calibration and performance are based on chemical and electrochemical principles, often with factory calibration and stability testing, rather than a data-driven training process.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. See the answer for point 8.
Summary of Device Performance (Based on "Indications for Use" and general knowledge of 510(k) for BGM systems):
While specific performance data is not provided, the FDA's clearance (K073494) indicates that the ACHTUNG TD-4207, Clever Check TD-4209, Clever Chek TD-4222, Clever Chek TD-4225, Clever Chek TD-4226 Blood Glucose Monitoring Systems demonstrated "substantial equivalence" to legally marketed predicate devices. This implies that the sponsor provided data (which is not in this document) to the FDA showing that these devices meet accepted performance standards for blood glucose meters, likely including accuracy and precision metrics comparable to the predicate devices and/or ISO 15197 standards.
The "Indications for Use" specifies:
- Intended Use: Quantitative measurement of glucose in fresh capillary whole blood from the finger and alternative sites (palm, forearm, upper-arm, calf, thigh).
- User: Healthcare professionals and people with diabetes mellitus at home.
- Purpose: Aid in monitoring the effectiveness of diabetes control program.
- Exclusions: Not for diagnosis or screening of diabetes mellitus, not for use on neonates.
- Limitation for ALT: Alternative site testing can be used only during steady-state blood glucose conditions.
To get the detailed information you are looking for (acceptance criteria, specific performance data, sample sizes, etc.), you would typically need to review the full 510(k) submission available through FDA's public access, which often includes a more detailed summary of safety and effectiveness data. This provided document is primarily the FDA's response letter and the indications for use.
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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
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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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§ 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.