(119 days)
The CLEVER CHEK TD-4232 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.
The alternative site testing in this 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.
CLEVER CHEK TD-4232 Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The provided text is a 510(k) summary for the CLEVER CHEK TD-4232 Blood Glucose Monitoring System. It describes the device, its intended use, comparison to a predicate device, and a general statement about performance studies. However, it lacks specific details regarding acceptance criteria and the results of the studies in a structured format.
Based on the provided text, I can infer some general information but cannot fill out all requested fields.
Here's an analysis of the provided text in relation to your questions:
1. Table of acceptance criteria and the reported device performance
The document states: "The studies demonstrated that the performance of this system meets its intended use." However, it does not provide a specific table or detailed quantitative acceptance criteria and reported performance values. For blood glucose monitoring systems, acceptance criteria typically involve accuracy standards (e.g., ISO 15197) which define thresholds for agreement with a laboratory reference method.
2. Sample size used for the test set and the data provenance
The document mentions "Performance Studies... in the laboratory and in clinical settings by healthcare professionals and lay users." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information about the number or qualifications of experts used to establish ground truth. For blood glucose meters, the "ground truth" is typically established by a highly accurate laboratory reference method, not by human experts interpreting results.
4. Adjudication method for the test set
The document does not specify any adjudication method. This is not typically relevant for a blood glucose meter's accuracy studies, as the comparison is usually against a quantitative laboratory reference.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
An MRMC study is relevant for imaging devices where human readers interpret results. This device is a blood glucose monitoring system that provides a quantitative measurement. Therefore, an MRMC study was not done and is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a "Blood Glucose Monitoring System" consisting of a "meter and test strips." It utilizes an "electrochemical method-based meter and dry reagent biosensor." This is a standalone device that provides a direct numerical reading. Therefore, performance a standalone (algorithm only) performance study was inherently performed as the device's output is the final result, not an interpretation that requires human input for final decision-making.
7. The type of ground truth used
For blood glucose monitoring systems, the ground truth is established by a highly accurate laboratory reference method (e.g., a YSI glucose analyzer). While the document doesn't explicitly state the type of reference method, this is the standard practice for such devices.
8. The sample size for the training set
The document does not provide any information regarding a training set sample size. For traditional electrochemical blood glucose meters, there isn't a "training set" in the machine learning sense. The device's calibration and algorithm are developed during manufacturing and validated through performance studies.
9. How the ground truth for the training set was established
As there's no mention of a "training set" in the machine learning context, the document does not describe how ground truth for a training set was established. Device calibration would involve comparisons to laboratory reference methods during development and manufacturing.
Summary of missing information:
The provided 510(k) summary is very high-level and does not include the detailed performance data, sample sizes, methodology specifics, or explicit acceptance criteria that you've requested. These details are typically found in the full 510(k) submission, not always in the summary document.
In conclusion, based solely on the provided text, I cannot complete your request comprehensively. The document confirms that performance studies were conducted and the device "demonstrates satisfactory performance and is suitable for its intended use," but it does not provide the specific data points needed to fill out your table or fully answer your questions.
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K073/119
510 (k) Summary
- Submitter Information Company name Contact person Address
Phone FAX E-mail
- Name of Device Trade Names
Common Names/Descriptions
Classification Names
MAR - 3 2008
Page 1-of-3
TaiDoc Technology Corporation Erica Li 4F, No. 88, Sec. 1, Kwang-Fu Rd, San-Chung, Taipei County, 241, Taiwan (886-2) 6635-8080 (886-2) 6635-5959 erica@taidoc.com
CLEVER CHEK TD-4232 Blood Glucose Monitoring System
Blood Glucose Meter Blood Glucose Test Strips Class II devices (21 CFR Section 862.1345, Glucose Test System)
- Predicate Device Trade/Proprietary Name:
Common/Usual Name:
Manufacturer 510 (k) Number Clever Chek TD-4223 Blood Glucose Monitoring System Blood Glucose Meter Blood Glucose Test Strips TaiDoc Technology Corporation K063212
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4. Device Description
CLEVER CHEK TD-4232 Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
5. Intended Use
CLEVER CHEK TD-4232 Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the finger and the alternative sites for self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities. Testing is done outside the body (in vitro diagnostic use).
The alternative site testing (the plam, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions.
This system contains speaker function which provides step by step instructions.
6. Comparison to Predicate Device
CLEVER CHEK TD-4232 Blood Glucose Monitoring System has equivalent technological characteristics as the Clever Chek TD-4223 blood glucose monitoring system (K063212). CLEVER CHEK TD-4232 Blood Glucose Monitoring System also has the same intended use as the lever Chek TD-4231 blood glucose monitoring system
7. Performance Studies
The performance of CLEVER CHEK TD-4232 Blood Glucose Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use.
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8. Conclusion
. .
CLEVER CHEK TD-4232 Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use.
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Image /page/3/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 curved lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Taidoc Technology Corporation c/o Ms. Erica Li Management Representative 4F. 88. Sec. 1. Kawang Fu Road San Chung, Taipei County Taiwan 241 China
MAR - 3 2008
Re: K073119
Trade/Device Name: Clever chek model td-4232 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 18, 2008 Received: February 20, 2008
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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Page 2 -
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 vours.
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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Attachment A
Indications for Use
510(k) Number: K073119
Device Name: CLEVER CHEK TD-4232 Blood Glucose Monitoring System
Indications for Use:
The CLEVER CHEK TD-4232 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.
The alternative site testing in this 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 | AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ | |
|---|---|---|
| (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)
Oa
Division Sign-Off
Office of In Vitro DiagnosticsDevice Evaluation and Safety
510(2) K073119
§ 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.