(149 days)
Not Found
No
The description focuses on electrochemical measurement and does not mention any AI/ML components or functionalities.
No.
The device is a blood glucose monitoring system intended for the quantitative measurement of glucose, which aids in monitoring the effectiveness of a diabetes control program, but it does not treat or prevent any condition.
No
The 'Intended Use / Indications for Use' section explicitly states, "It is not intended for the diagnosis of or screening for diabetes mellitus." While it measures glucose, its purpose is for monitoring effectiveness of diabetes control, not for initial diagnosis.
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 a "blood glucose monitoring system" consisting of a meter and test strips that utilize an "electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing". This describes the components and method used to perform the in vitro test.
- Purpose: The purpose is to aid in "monitoring the effectiveness of diabetes control program", which is a diagnostic purpose related to a medical condition.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 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 the Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.
Professionals may use the Clever Chek TD-4209/ Clever Chek TD-4222 Blood/ Clever Chek TD-4225 glucose monitoring system to test neonatal blood ' from the heel, but may not be used in screening for neonatal hypoqlycemia.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 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, palm, forearm, upper-arm, calf, thigh, heel (for neonates)
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-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 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): 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.
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.
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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UCT 2 5
510 (k) Summary
- Submitter Information Company name Contact person Address
Phone FAX E-mail Date Prepared
- Name of Device Trade Names
Common Names/Descriptions
Classification Names
- Predicate Device Trade/Proprietary Name: Common/Usual Name: Manufacturer 510 (k) Number
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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 May 29th , 2007
Clever Chek TD-4209 Blood glucose monitoring system Clever Chek TD-4222 Blood glucose monitoring system Clever Chek TD-4225 Blood glucose monitoring system Blood Glucose Meter Blood Glucose Test Strips Class II devices (21 CFR Section 862.1345, Glucose Test System)
ACCU-CHEK Aviva test strips Blood Glucose test system Roche Diagnostics K060620
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4. Device Description
Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 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-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 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.
Limited to professionals, this system can also test on neonate blood, where is from the heel.
6. Comparison to Predicate Device
Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 blood glucose monitoring system has equivalent technological characteristics as the ACCU-CHEK Aviva blood glucose test system (K060620). Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 blocd glucose monitoring system also has the similar intended use as the ACCU-CHEK Aviva blood glucose test system
7. Performance Studies
The performance of Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 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-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 blood glucose monitoring system demonstrates satisfactory performance and is suitable for its intended use.
V
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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, Kwang Fu Road San Chung, Taipei County, Taiwan 241
OCT 26 2007
Re: K071493
Trade Name: Clever Chek TD-4209 Blood Glucose Monitoring System, Clever Chek TD-4222 Blood Glucose Monitoring System, Clever Chek TD-4225 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: October 15, 2007 Received: October 18, 2007
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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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.
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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Indications for Use
510(k) Number: K071493
Device Name: Clever Chek TD-4209 Blood glucose monitoring system Clever Chek TD-4222 Blood glucose monitoring system Clever Chek TD-4225 Blood glucose monitoring system Indications for Use:
The Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 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 the Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.
Professionals may use the Clever Chek TD-4209/ Clever Chek TD-4222 Blood/ Clever Chek TD-4225 glucose monitoring system to test neonatal blood ' from the heel, but may not be used in screening for neonatal hypoqlycemia.
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)
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Carol Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Vision Sign-Off
ිffice of In Vitro Diagnostic Device Evaluation and Safe
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