(119 days)
No
The summary describes a standard electrochemical blood glucose monitoring system with a speaking function for accessibility. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The "Intended Use / Indications for Use" section states that the device is an "aid in monitoring the effectiveness of diabetes control program," not for treating or curing the condition itself. Thus, it is a diagnostic/monitoring device, not a therapeutic one.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not intended for the diagnosis of or screening for diabetes mellitus." It is intended as an aid in monitoring the effectiveness of a diabetes control program.
No
The device description explicitly states that the system consists of a meter and test strips, which are hardware components.
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 is a measurement performed in vitro (outside the body) on a biological sample (blood).
- Device Description: The description details the use of a "dry reagent biosensor (test strips)" and an "electrochemical method-based meter". These are components and methods commonly used in IVD devices for analyzing biological samples.
- Function: The core function is to measure a substance (glucose) in a biological fluid (blood) to aid in monitoring a medical condition (diabetes). This is a hallmark of an IVD.
The fact that it's used by healthcare professionals and people with diabetes at home further supports its classification as an IVD, as IVDs are designed for use in clinical settings and by lay users for self-testing.
N/A
Intended Use / Indications for 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.
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.
Product codes
NBW, CGA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, the palm, the forearm, the upper-arm, the calf and the thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
Not Found
§ 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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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.
2
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
5
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