(158 days)
Not Found
No
The summary describes standard electrochemical and oscillometric methods for glucose and blood pressure measurement, with no mention of AI or ML algorithms for data analysis, interpretation, or prediction.
No
The device is a monitoring system that measures glucose, blood pressure, and pulse rate, and is not intended for the diagnosis or treatment of a disease or condition. It aids in monitoring the effectiveness of a diabetes control program, which is a diagnostic or monitoring function rather than 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." While it measures glucose, blood pressure, and pulse rate, its purpose is for monitoring effectiveness of diabetes control and general health, not for initial diagnosis.
No
The device description explicitly states that the system "consists of a monitor with arm cuff and test strips," indicating the presence of significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the quantitative measurement of glucose in fresh capillary whole blood. This is a diagnostic test performed on a biological sample (blood) outside of the body (in vitro).
- Device Description: The device description details the use of an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. This is a typical setup for an in vitro diagnostic device that analyzes a biological sample using chemical reactions.
While the device also measures blood pressure, which is a physiological measurement and not an in vitro diagnostic, the blood glucose monitoring component clearly falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure 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 palm, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions. The system is also intended to be used to non-invasively measure the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" ~ 13.8". Above systems offer wireless communication function which is able to transfer the test result to other devices, such as PC.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, DXN
Device Description
Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system consists of a monitor with arm cuff 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 system is able to provide blood pressure measurement which adopts the "oscillometric method" as the measuring principle. It provides the systolic pressure, diastolic blood pressure and pulse rate on an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4"~13.8" (24 ~35 cm) for am.
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, arm (for blood pressure cuff).
Indicated Patient Age Range
Adult individual, over age 16.
Intended User / Care Setting
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-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the above blood glucose plus blood pressure monitoring system is suitable for its intended use.
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.
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.
0
510 (k) Summary
K0800J4
Page 1-of-3
| 1. Submitter Information | JUN - 9 2008 | ||
|---|---|---|---|
| Company name | TaiDoc Technology Corporation | ||
| Contact person | Yuhua Chen | ||
| Address | 6F, No.127, Wugong 2nd Rd., | ||
| Wugu Township, Taipei County, | |||
| 248, Taiwan | |||
| Phone | (886-2) 6625-8188 | ||
| FAX | (886-2) 6625-0288 | ||
| yuhua.chen@taidoc.com.tw | |||
| 2. Name of Device | |||
| Trade Names | - Clever Chek TD-3250C Blood | ||
| Glucose plus Blood pressure Monitoring | |||
| System |
- Clever Chek TD-3250D Blood
Glucose plus Blood pressure Monitoring
System - Fora Comfort 2 in 1 Blood
Glucose plus Blood Pressure
Monitoring System | | |
| Common Names/Descriptions | - Blood Glucose and Blood Pressure
Measurement System - Blood Glucose Test Strips | | |
| Classification Names | - Class II devices - 21 CFR Section 862.1345, Glucose Test
System - 21 CFR Section 870.1130, Non-invasive
Blood Pressure Measurement System | | |
Page 2-of-3
:
1
| 3. Predicate Device | |
|---|---|
| Trade/Proprietary Name: | Clever Chek TD-3250 Blood Glucose plus |
| Blood Pressure Monitoring System | |
| Common/Usual Name: | - Blood Glucose and Blood Pressure |
| Measurement System |
- Blood Glucose Test Strips |
| Manufacturer | TaiDoc Technology Corporation |
| 510 (k) Number | K062800 NBW, CGA, DXN |
4. Device Description
Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system consists of a monitor with arm cuff 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 system is able to provide blood pressure measurement which adopts the "oscillometric method" as the measuring principle. It provides the systolic pressure, diastolic blood pressure and pulse rate on an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4"~13.8" (24 ~35 cm) for am.
5. Intended Use
Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure 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).
2
The alternative site testing (the palm, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions.
The system is also intended to be used to non-invasively measure the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" ~ 13.8".
Above systems offer wireless communication function which is able to transfer the test result to other devices, such as PC.
6. Comparison to Predicate Device
Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system has equivalent technological characteristics and intended use as the Clever Chek TD-3250 blood glucose plus blood pressure monitoring system (K062800).
7. Performance Studies
The performance of Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the above blood glucose plus blood pressure monitoring system is suitable for its intended use.
8. Conclusion
Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system demonstrate satisfactory performance and are suitable for their intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
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, 241 Taiwan (ROC)
JUN = 9 2008
Re: K080014
Trade/Device Name: Clever Chek TD-3250C Blood Glucose plus Blood Pressure Monitoring System
Clever Chek TD-3250D Blood Glucose plus Blood Pressure Monitoring System
Fora Comfort 2 in 1 TD-3260 Blood Glucose plus Blood Pressure Monitoring System
Regulation Number: 21 CFR 862.1345
Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, CGA, DXN Dated: June 3, 2008 Received: June 4, 2008
Dear Mr. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowled your or your we 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 I ou may, iteretory manns 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 It may be bable 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 I loast be advisou and I DTT 3 issuantes vour device complies with other requirements of the Act that I Driving and regulations administered by other Federal agencies. You must or any I otoral butther and regulanents, 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).
4
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.
Téan 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
Indication for Use
510(k) Number: (080014
Device Name:
Clever Chek TD-3250C Blood Glucose plus Blood pressure Monitoring System Clever Chek TD-3250D Blood Glucose plus Blood pressure Monitoring System Fora Comfort 2 in 1 Blood Glucose plus Blood Pressure Monitoring System
Indication For Use:
The Clever Chek TD-3250C Blood Glucose plus Blood pressure Monitoring System / Clever Chek TD-3250D Blood Glucose plus Blood pressure Monitoring System / Fora Comfort 2 in 1 Blood Glucose plus Blood Pressure 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 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.
The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home.
The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" - 13.8".
This system offers wireless communication function which is able to transmit the test result to other devices, such as PC,
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safe 510(k)
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