(30 days)
The FORA TD-4245 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-4245 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The FORA TD-4245 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
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This document is a 510(k) clearance letter for the FORA TD-4245 Blood Glucose Monitoring System, not a study report. Therefore, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.
However, based on the information provided in this regulatory document, I can infer and state what is available:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria nor reported device performance data. 510(k) clearance letters generally confirm that a device has been found substantially equivalent to a predicate device, rather than detailing the specific performance metrics and acceptance thresholds met by the applicant device. Such detailed data would typically be in the 510(k) submission itself, which is not provided here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided 510(k) clearance letter. In the context of a blood glucose monitor, "ground truth" would typically be established by a reference laboratory method, not by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided 510(k) clearance letter.
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
A blood glucose monitoring system is a diagnostic device that measures a physiological parameter. It does not involve "readers" in the context of image interpretation or clinical decision-making that would necessitate an MRMC study or AI assistance for human readers. Therefore, this type of study is not applicable to this device and no such information is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This statement is also not applicable in the typical sense for a blood glucose meter. The device itself is an "algorithm only" device in that it processes a blood sample to provide a glucose reading. Its performance is evaluated in direct comparison to a reference method (e.g., YSI analyzer), rather than requiring a "human-in-the-loop" for interpretation of the primary result. The mentioned "speaking functionality" aids visually impaired persons, but this is an accessibility feature, not part of the core diagnostic algorithm's standalone performance evaluation methodology.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a blood glucose monitoring system, the "ground truth" is typically established by measurements from a highly accurate and precise reference laboratory instrument, such as a YSI glucose analyzer. The clearance letter does not explicitly state this, but it is the standard practice for validating such devices.
8. The sample size for the training set
This information is not available in the provided 510(k) clearance letter.
9. How the ground truth for the training set was established
This information is not available in the provided 510(k) clearance letter. As mentioned in point 7, it would typically be established using a reference laboratory instrument.
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Public Health Service
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FEB 5 - 2009
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Taidoc Technology Corporation c/o Yuhua Chen, Assistant Manager, Regulatory Affairs 6F, No.127, Wugong 2nd Rd, Wugu Taipei County China (Taiwan) 248
Re: K083664
Trade/Device Name: FORA TD-4245 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 12, 2008 Received: December 10, 2008
Dear Yuhua Chen:
This letter corrects our substantially equivalent letter of January 9, 2009.
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 A
Indications for Use
510(k) Number:
Device Name: FORA TD-4245 Blood Glucose Monitoring System
Indications for Use:
The FORA TD-4245 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-4245 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The FORA TD-4245 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
Prescription Use (21 CFR Part 801 Subpart D) And/Or 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 (OIVD)
Cawl C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083664
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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.