(182 days)
The FORA TD-4244 Blood Glucose 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 forearm, 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, and is not intended for use on neonates.
The alternative site testing in the FORA TD-4244 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The FORA TD-4244 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
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The FDA 510(k) summary for the FORA TD-4244 Blood Glucose Monitoring System (K081715) provides some information about device performance but does not include a detailed study description with all the requested elements. However, I can extract the available information to construct a response.
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to the ISO 15197:2003 standard, which defines accuracy criteria for blood glucose monitoring systems.
| Acceptance Criteria (ISO 15197:2003) | Reported Device Performance (FORA TD-4244) |
|---|---|
| For Glucose Concentrations < 75 mg/dL (4.2 mmol/L): Minimum 95% of results must be within ± 15 mg/dL (0.83 mmol/L) of the reference method. | For glucose concentration < 75 mg/dL: 98.2% of results were within ± 15 mg/dL. |
| For Glucose Concentrations ≥ 75 mg/dL (4.2 mmol/L): Minimum 95% of results must be within ± 20% of the reference method. | For glucose concentration ≥ 75 mg/dL: 98.0% of results were within ± 20%. |
| Combined Accuracy: Minimum 95% of results must meet the respective criteria (both < 75 mg/dL and ≥ 75 mg/dL). | 98.1% of results met the criteria, satisfying the requirement to have at least 95% of results within the specified accuracy ranges for both categories. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: 100 participants.
- Data Provenance: The document states "Clinical study results: The study was performed by collecting fingerstick blood samples from 100 participants." This implies a prospective clinical study. The country of origin for the data is not explicitly mentioned but can be inferred to be China (Taiwan) based on the manufacturer's address.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This information is not provided in the given document. For blood glucose meters, the "ground truth" (reference method) is typically established by laboratory-grade analyzers, not human experts in the traditional sense.
4. Adjudication Method for the Test Set:
- This information is not applicable as the ground truth is established by a reference method, not by expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human-Reader Improvement with AI vs. without AI Assistance:
- This information is not applicable as the device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, the performance data presented is for the standalone device (FORA TD-4244 Blood Glucose Monitoring System) against a reference laboratory method. Human intervention is limited to sample collection and device operation, not interpretation of an algorithm's output.
7. The Type of Ground Truth Used:
- The ground truth was established using a reference laboratory method. The specific name of the reference method is not explicitly stated in the provided text, but for glucose monitoring systems, a common reference is a YSI 2300 STAT Plus Glucose & Lactate Analyzer or similar laboratory photometric methods.
8. The Sample Size for the Training Set:
- This information is not provided. Blood glucose meters are typically calibrated during manufacturing, and a "training set" in the context of machine learning is not directly applicable to traditional medical devices like this. The ISO 15197 study describes a validation study, not a training process.
9. How the Ground Truth for the Training Set Was Established:
- This information is not provided and is generally not applicable in the context of device calibration versus machine learning model training.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Yuhua Chen Assistant Manager, Regulatory Affairs Taidoc Technology Corporation 6F, No.127, Wugong 2nd Rd, Wugu Taipei County China (Taiwan) 248
K081715 Re:
Trade/Device Name: FORA TD-4244 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: November 14, 2008 Received: November 17, 2008
FEB 5 - 2009
Dear Yuhua Chen:
This letter corrects our substantially equivalent letter of December 17, 2008.
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Corg C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Attachment 1
Indications for Use
510(k) Number: K081715
Device Name: FORA TD-4244 Blood Glucose Monitoring System
Indications for Use:
The FORA TD-4244 Blood Glucose 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 forearm, 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, and is not intended for use on neonates.
The alternative site testing in the FORA TD-4244 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The FORA TD-4244 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
Prescription Use And/Or Over the Counter Use __ X (21 CFR Part 801 Subpart D) (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)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081715
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.