(46 days)
Not Found
No
The device description details standard electrochemical and oscillometric methods for measurement, with no mention of AI or ML algorithms for data analysis or interpretation. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is for diagnostic use (measuring blood glucose and blood pressure) to monitor effectiveness of a diabetes control program, not for therapeutic intervention or treatment.
Yes
The device is intended for "in vitro diagnostic use" and provides "quantitative measurement of capillary whole blood from the fingertip" and "systolic and diastolic blood pressure and pulse rate", which are all diagnostic measurements. However, it's explicitly stated that it is "not intended for the diagnosis of or screening for diabetes mellitus". Regardless, measuring blood glucose and blood pressure for monitoring purposes as an "aid in monitoring the effectiveness of a diabetes control program" falls under the umbrella of diagnostic devices, as it provides information about a patient's health status.
No
The device description explicitly states that the system consists of a meter with arm cuff and test strips, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Clever Chek TD-3250 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use."
This statement directly identifies the blood glucose measurement function of the device as an in vitro diagnostic. While the device also measures blood pressure, the blood glucose measurement component falls under the definition of an IVD because it involves testing a sample (capillary whole blood) outside of the body to obtain diagnostic information (glucose levels).
N/A
Intended Use / Indications for Use
The CLEVER CHEK TD-3250™ system is indicated for the quantitative measurement of glucose in fresh whole blood (capillary blood) 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 system also intended to use non-invasive measure the systolic and diastolic blood pressure and pulse rate or an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the . The arm cuff circumference is limited to 9.4"~13.8".
The Clever Chek TD-3250 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary whole blood from the fingertip. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a 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 system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pluse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4 inches to ~ 13.8 inches.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX, DXN
Device Description
The CLEVER CHEK TD-3250™ blood glucose and blood pressure measurement system consists of a meter 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. Also, the system adopts the "oscillometric method" to as the measuring principle and provides the measurement of the systolic and diastolic blood pressure and heart rate of an individual by using a non-invasive technique in which as inflatable cuff is wrapped around the . The pressure sensor converts tiny alterations in arm cuff pressure to electrical signals, by analyzing those signals to determine the systolic and diastolic blood pressure and calculating pulse rate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm (for blood pressure measurement), Fingertip (for blood glucose measurement)
Indicated Patient Age Range
Over age 16 (for blood pressure measurement); Not for use on neonates (for blood glucose measurement)
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 the CLEVER CHEK TD-3250™ system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the CLEVER CHEK TD-3250™ system is suitable for 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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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Page 1-of-3
JUN - 2 2006
510 (k) Summary
- Submitter Information Manufacturer 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
TaiDoc Technology Corporation Shu-Mei Wu 4F, No. 88, Sec. 1, Kwang-Fu Rd., San-Chung, Taipei County, Taiwan +886-2-66358080 +886-2-66355959 shumei@taidoc.com.tw April 14, 2006
CLEVER CHEK TD-3250TM
Blood Glucose and Blood Pressure Measurement System Blood Glucose and Blood Pressure Measurement System Blood Glucose Test Strips Class II devices 21 CFR Section 862.1345, Glucose Test System; 21 CFR Section 870.1130, Non-invasive Blood Pressure Measurement System
Achtung TD-4207 Blood Glucose Test System BpTRU Automated Non-Invasive Blood Pressure Monitoring, BMP-100 Blood Glucose Meter; Non-invasive Blood Pressure Measurement System Blood Glucose Test Strips TaiDoc Technology Corporation. VSM MedTech Ltd. K042005; K012636
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4. Device Description
The CLEVER CHEK TD-3250™ blood glucose and blood pressure measurement system consists of a meter 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. Also, the system adopts the "oscillometric method" to as the measuring principle and provides the measurement of the systolic and diastolic blood pressure and heart rate of an individual by using a non-invasive technique in which as inflatable cuff is wrapped around the . The pressure sensor converts tiny alterations in arm cuff pressure to electrical signals, by analyzing those signals to determine the systolic and diastolic blood pressure and calculating pulse rate.
5. Intended Uses
The CLEVER CHEK TD-3250™ system is indicated for the quantitative measurement of glucose in fresh whole blood (capillary blood) 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 system also intended to use non-invasive measure the systolic and diastolic blood pressure and pulse rate or an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the . The arm cuff circumference is limited to 9.4"~13.8".
6. Comparison to Predicate Device
The CLEVER CHEK TD-3250™ system has equivalent technological characteristics as the Achtung TD-4207 Blood Glucose Test System (K042005) and BpTRU Automated Non-invasive Blood Pressure Monitor, BP-100 (K012636). The CLEVER CHEK TD-3250™ system also has the same intended use as the Achtung TD-4207 Blood Glucose Test System and BpTRU Automated Non-invasive Blood Pressure Monitor, BP-100.
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7. Performance Studies
The performance of the CLEVER CHEK TD-3250™ system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the CLEVER CHEK TD-3250™ system is suitable for its intended use
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Page 3-of-3
- Conclusions
The CLEVER CHEK TD-3250™ system demonstrates satisfactory performance and is suitable for their intended uses.
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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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 5 2006
Shu-Mei Wu, Ph.D. Project Manager Taidoc Technology Corporation 4F, 88, Sec.1, Kwang Fu Road San Chung, Taipei China (Taiwan) 241
K061073 Re: Trade/Device Name: Clever Chek TD-3250 Blood Glucose and Blood Pressure Measurement System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX, DXN Dated: April 14, 2006 Received: April 17, 2006
Dear Dr. Shu-Mei Wu:
This letter corrects our substantially equivalent letter of June 2, 2006.
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.
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Page 2 - Dr. Shu-Mei Wu
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).
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)276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Carol Benson for
Alberto Gutierrez Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics Device Evaluation and Safety Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K061073
Device Name: Clever Chek TD-3250 Blood Glucose and Blood Pressure Measurement System
Indications For Use:
The Clever Chek TD-3250 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary whole blood from the fingertip. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a 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 system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pluse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4 inches to ~ 13.8 inches.
Prescription Use (Part 21 CFR 801 Subpart D)
Image /page/5/Picture/7 description: The image shows the text "AND/OR" with a circle around it. The text is written in all capital letters. The circle is drawn around the entire text.
Over-The-Counter Use (21 CFR 801 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)
Carol C. Benson
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K061073