(673 days)
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No
The document describes a standard electrochemical blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No.
The device is for monitoring glucose levels as an aid in managing diabetes, not for treating the condition itself.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is not intended for the diagnosis of or screening for diabetes mellitus."
No
The device description explicitly states the system utilizes an "electrochemical method-based meter and dry reagent biosensor (test strips)" for blood glucose testing, indicating the presence of hardware components beyond just software.
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 with fresh capillary whole blood from the finger and venous whole blood samples." This involves testing a biological sample (blood) in vitro (outside the body) to obtain diagnostic information (glucose levels).
- Device Description: The description details an "electrochemical method-based meter and dry reagent biosensor (test strips)" used for "blood glucose testing." This further confirms the in vitro nature of the testing process.
- Purpose: The system is intended as an "aid in monitoring the effectiveness of diabetes control program." While not for diagnosis or screening, monitoring glucose levels is a key aspect of managing a disease, which falls under the scope of IVDs.
The fact that it's used by healthcare professionals in healthcare facilities and involves testing blood samples outside the body clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FORA POCT S10 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. It is indicated for multiple patients use by health care professionals in health care facilities as an aid in monitoring the effectiveness of diabetes control program. The system is only used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus. It is not intended for use on neonates.
The FORA POCT S10 Blood Glucose test strips are for the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. The FORA POCT S10 test strips are for use only with the FORA POCT S10 Blood Glucose meter.
Product codes
LFR
Device Description
The FORA POCT S10 Blood Glucose Monitoring System is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The test principle of the system utilize 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 whole blood and control solutions.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
finger (for fresh capillary whole blood), venous (for venous whole blood samples)
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
health care professionals in health care facilities
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of FORA POCT S10 Blood Glucose Monitoring System has the same performance characteristics as the predicate device.
The studies of software verification and validation testing, system accuracy, and meter reliability test demonstrated that the performance of this system meets its intended use.
FORA POCT S10 Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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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:
| 1. Submitter Information | |
|---|---|
| Company name | TaiDoc Technology Corporation |
| Contact person | Teling Hsu |
| Address | 3F, 5F, No. 127, Wugong 2nd Rd, |
| Wugu Township, Taipei County, | |
| 24888, Taiwan | |
| Phone | (+886-2) 6625-8188 #1176 |
| FAX | (+886-2) 6625-0288 |
| teling.hsu@taidoc.com.tw | |
| Date Prepared | July 4th, 2011 |
| 2. Name of Device | |
| Proprietary Names | FORA POCT S10 Blood Glucose |
| Monitoring System | |
| Monitoring System | |
| Common Name | Blood Glucose Test System |
| Classification Name | Class II devices |
| (21 CFR Section 862.1345) | |
| Product Code | LFR |
| 3. Predicate Device | |
|---|---|
| Trade/Proprietary Name: | TaiDoc Professional Glucose Test Strips |
| Common/Usual Name: | Blood Glucose Test System |
| Manufacturer | TaiDoc Technology Corporation |
| 510 (k) Number | K082169 |
4. Device Description
The FORA POCT S10 Blood Glucose Monitoring System is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The test principle of the system utilize 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
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measurement of glucose in whole blood and control solutions.
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- Intended Use
The FORA POCT S10 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. It is indicated for multiple patients use by health care professionals in health care facilities as an aid in monitoring the effectiveness of diabetes control program. The system is only used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus. It is not intended for use on neonates.
- Intended Use
The FORA POCT S10 Blood Glucose test strips are for the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. The FORA POCT S10 test strips are for use only with the FORA POCT S10 Blood Glucose meter.
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- Comparison to Predicate Device
The proposed FORA POCT $10 Blood Glucose Meter is in conjunction with TaiDoc Pro l Glucose Test Strips which is cleared as the predicate device and work with the proposed device as a functional system.
- Comparison to Predicate Device
This system use amperometry for blood glucose measurement. The test is based on the measurement of electrical current generated by the reaction of glucose with reagents of the strip.
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- Performance Studies
The performance of FORA POCT S10 Blood Glucose Monitoring System has the same performance characteristics as the predicate device.
- Performance Studies
The studies of software verification and validation testing, system accuracy, and meter reliability test demonstrated that the performance of this system meets its intended use.
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- Conclusion
FORA POCT S10 Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use.
- Conclusion
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Image /page/2/Picture/3 description: The image shows a date, "JUL 06 2011". The date is written in a bold, sans-serif font. The month is abbreviated to "JUL", and the year is "2011". The date is likely a stamp or a label.
TaiDoc Technology Corporation c/o Ms. Teling Hsu Regulatory Affairs Specialist 3F, 5F, No. 127, Wugong 2nd Road, Wugu Township Taipei County, Taiwan 24888
Re: K092688
Trade/Device Name: FORA POCT S10 Blood Glucose Monitoring System Regulation Number: 21 CFR 862. 1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR Dated: June 28, 2011 Received: June 30, 2011
Dear Ms. Hsu:
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 class II (Special Controls), 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).
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of Americans.
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
G.C.
Courmey 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: K092688
Device Name: FORA POCT S10 Blood Glucose Monitoring System
Indications for Use:
The FORA POCT S10 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. It is indicated for multiple patients use by health care professionals in health care facilities as an aid in monitoring the effectiveness of diabetes control program. The system is only used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus. It is not intended for use on neonates.
The FORA POCT S10 Blood Glucose test strips are for the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. The FORA POCT S10 test strips are for use only with the FORA POCT S10 Blood Glucose meter.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
Signature
Division Sign-off Office of In Vitro Diagnostic Devices Evaluation and Safety 510(k)_KOY26
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