(98 days)
No
The summary describes a standard blood glucose and blood pressure monitoring system and does not mention any AI or ML capabilities.
No.
The device is for monitoring blood glucose, blood pressure, and pulse rate, which aids in managing conditions like diabetes, but it does not directly treat or cure them.
No
The device description explicitly states, "The device is not to be used for the diagnosis or screening of diabetes, hypertension or for testing on neonates." It is intended as an aid in monitoring the effectiveness of a diabetes control program and to measure blood pressure and pulse rate.
No
The device description explicitly states the kit consists of four main products: the monitor (which features both blood glucose and blood pressure measurement functions), test strips, control solutions, and the lancet device. These are all hardware components.
Based on the provided text, the ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System is an IVD (In Vitro Diagnostic) device, but only for the blood glucose monitoring function.
Here's why:
- Intended Use: The text explicitly states the device is intended for the "quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites...". This involves testing a biological sample (blood) outside of the body to obtain information about a physiological state (blood glucose levels). This aligns with the definition of an in vitro diagnostic device.
- Device Description: The description mentions "test strips" and "control solutions," which are components typically used in IVD devices for chemical analysis of biological samples.
- Predicate Device: The predicate device (K070641) is also described as a "blood glucose plus blood pressure monitoring system," suggesting the glucose monitoring component of the predicate was also considered an IVD.
However, the blood pressure monitoring function is NOT an IVD.
- Intended Use: The blood pressure measurement is described as "non-invasively" measuring blood pressure and pulse rate using a cuff. This is a physical measurement taken on the body, not an analysis of a biological sample outside the body.
Therefore, the device is a combination device with both IVD and non-IVD functions. The blood glucose monitoring part is an IVD.
N/A
Intended Use / Indications for Use
ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, model no. TD-3223E is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, forearm, upper-arm, calf and 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. The alternative site testing in the system can be used only during steady-state blood glucose conditions.
The system is also intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25" to 7.75".
The device is not to be used for the diagnosis or screening of diabetes, hypertension or for testing on neonates.
Product codes
NBW, CGA, DXN
Device Description
The kit of ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System consist of four main products: the monitor features both the blood glucose and blood pressure measurement functions, test strips, control solutions (cleared under K041107), and the lancet device. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.
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, wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals and people with diabetes mellitus at home
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)
Software verification and validation testing confirmed that the performance, safety and effectiveness of the ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System is equivalent to the predicate device.
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
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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FEB 2 5 2010
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The Assigned 510(k) number is: K093592
-
- Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
Correspondence: Debra Liang Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1198 Fax: +886-2-6625-0288 Email: debra.liang@taidoc.com.tw
- Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
-
- Device name:
Proprietary name: ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressurc Monitoring System, model no. TD-3223E
- Device name:
Regulatory information:
| A. | Regulation section: | 21 CFR § 862.1345, Glucose Test System |
|---|---|---|
| 21 CFR §870.1130, Noninvasive blood pressure | ||
| measurement system | ||
| B. | Classification: | Class II (Glucose Test System) |
| Class II (Blood Pressure Measurement System) | ||
| C. | Product Code: | NBW, System, Test, Blood Glucose, Over The Counter |
| CGA, Glucose Oxidase, Glucose | ||
| DXN, System, Measurement, Blood-Pressure, Non-Invasive | ||
| D. | Panel: | 75, Clinical Chemistry - Glucose Test System |
| 74, Cardiovascular - Blood Pressure Measurement System |
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3. Intended Use:
ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, model no. TD-3223E is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, forearm, upper-arm, calf and 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. The alternative site testing in the system can be used only during steady-state blood glucose conditions.
The system is also intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25" to 7.75".
The device is not to be used for the diagnosis or screening of diabetes, hypertension or for testing on neonates.
-
- Device Description:
The kit of ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System consist of four main products: the monitor features both the blood glucose and blood pressure measurement functions, test strips, control solutions (cleared under K041107), and the lancet device. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.
- Device Description:
-
- Substantial Equivalence Information:
Predicate device name: A.
- Substantial Equivalence Information:
ADVOCATE DUO blood glucose plus blood pressure monitoring system
- B. Predicate K number: K070641
C. Comparison with predicate:
The modified ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System has the following similarities to the predicate device:
- same operating principle,
- same fundamental scientific technology,
- incorporate the same basic circuit design, 트
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- incorporate the same materials,
- same shelf life
- packaged using the same materials, and
- 미 Manufactured by the same process.
The modifications encompass:
- 통 A modification in the software of the glucose meter
- l Modification in the physical appearance
- Labeling change due to the software modification 트
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- Test Principle:
For blood glucose, the detection and measurement is by an electrochemical biosensor technology using glucose oxidase.
For blood pressure, the measurement is by using oscillometric, non-invasive blood pressure (systolic and diastolic) measuring technology.
7. Performance Characteristics:
The ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System has the same performance characteristics as the predicate device.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System is equivalent to the predicate device.
-
- Conclusion:
Based on the information provided in this submission, the ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System is substantially equivalent to the predicate ADVOCATE DUO blood glucose plus blood pressure monitoring system.
- Conclusion:
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
TaiDoc Technology Corporation c/o Debra Liang 6F, No. 127, Wugong 2nd Rd., Wugu Township Taipei County, China (Taiwan) 248
FEB 2 5 2010
Re: K093592
Trade Name: ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, model TD-3223E
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, DXN Dated: January 18, 2010 Received: January 26, 2010
Dear Ms. Liang:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. 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: K093592
Device Name: ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, model no. TD-3223E
Indications for Use:
ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, model no. TD-3223E is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, forearm, upper-arm, calf and 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. The alternative site testing in the system can be used only during steady-state blood glucose conditions.
The system is also intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5,25'' to 7.75".
The device is not to be used for the diagnosis or screening of diabetes, hypertension or for testing on neonates.
This monitor contains some speaking functions but is not intended for use by the visually impaired.
And/Or Prescription Use ____________ X (21 CFR Part 801 Subpart D)
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 (OVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)
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