(673 days)
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.
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.
The provided 510(k) summary for the FORA POCT S10 Blood Glucose Monitoring System is very brief on the details of its performance studies. As such, a significant portion of the requested information cannot be extracted from this document.
Here's what can be gathered and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. Performance characteristics of the predicate device (TaiDoc Professional Glucose Test Strips) are implied as the benchmark. | "The performance of FORA POCT S10 Blood Glucose Monitoring System has the same performance characteristics as the predicate device." |
| Specific performance metrics (e.g., accuracy against a lab reference, precision, linearity) are not provided in this summary. | "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." (No specific results given) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. For blood glucose monitoring systems, the "ground truth" is typically established by comparative measurements against a laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer), not by human experts adjudicating images.
4. Adjudication method for the test set
- Not applicable as the ground truth is established by a reference laboratory method, not by expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a blood glucose monitoring system, not an AI-powered diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, implicitly. Blood glucose meters operate in a standalone manner, providing a direct measurement. The "algorithm" here refers to the electrochemical method used by the device to convert the electrical current into a glucose concentration. The performance studies mentioned (system accuracy, meter reliability) would represent standalone performance.
7. The type of ground truth used
- The document does not explicitly state the type of ground truth used. However, for blood glucose monitoring systems, the ground truth is typically established by comparison to a laboratory reference method (e.g., a central laboratory analyzer such as a YSI glucose analyzer) on the same blood samples. This is commonly referred to in performance studies for such devices, even if not explicitly detailed in this summary.
8. The sample size for the training set
- Not applicable in the context of this traditional medical device. This device does not appear to be an AI/Machine Learning device that utilizes a "training set" in the conventional sense. Its performance is based on the underlying chemical/electrochemical principles and calibration, not on a learned model.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for this type of device.
Summary of Missing Information:
The 510(k) summary provides minimal detail regarding the performance studies. Key missing information includes:
- Specific numerical acceptance criteria for accuracy (e.g., bias, CV, % within clinical error limits like ISO 15197 standards).
- Detailed results of the system accuracy study.
- Sample sizes for performance evaluations (e.g., number of subjects, number of blood samples).
- Details of the reference method used for ground truth and its performance characteristics.
- Information about the study design (e.g., site, demographics of participants, full blood glucose range tested).
This brevity is common in 510(k) summaries, which are intended to be high-level overviews. The more detailed performance data would typically be found in the full 510(k) submission not publicly available, or in a separate clinical study report if one was published.
{0}------------------------------------------------
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
{1}------------------------------------------------
measurement of glucose in whole blood and control solutions.
-
- 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.
-
- 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.
-
- 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.
-
- Conclusion
FORA POCT S10 Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use.
- Conclusion
{2}------------------------------------------------
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.
{3}------------------------------------------------
Page 2 -
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
{4}------------------------------------------------
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
Page 1 of -
§ 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.