(28 days)
The UltraTRAK PRO 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 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 UltraTRAK PRO Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Not Found
This FDA 510(k) summary does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets them in the format requested. The document is a clearance letter for a medical device (UltraTRAK PRO Blood Glucose Monitoring System), stating that it has been found substantially equivalent to a predicate device. While it mentions regulatory numbers and product codes, it does not provide the specific performance data, study design, or ground truth establishment details.
Therefore, I cannot fulfill your request to create the table and provide the specific information about:
- A table of acceptance criteria and the reported device performance: This document does not include a table comparing acceptance criteria to performance data.
- Sample sizes used for the test set and the data provenance: Not mentioned in this document.
- Number of experts and their qualifications: Not mentioned in this document.
- Adjudication method: Not mentioned in this document.
- MRMC comparative effectiveness study: This is for a blood glucose monitor, not typically an AI-assisted diagnostic imaging device, so this type of study is unlikely to be relevant or present.
- Standalone performance: While the device performs standalone, the specific metrics of its standalone performance are not detailed here.
- Type of ground truth used: Not mentioned in this document. For a blood glucose monitor, ground truth would typically be a laboratory reference method (e.g., YSI analyzer), but this document doesn't specify.
- Sample size for the training set: Not mentioned in this document. (Blood glucose monitors usually don't have "training sets" in the AI sense; they are calibrated devices).
- How the ground truth for the training set was established: Not mentioned.
Summary of available information related to your request:
- Device Name: UltraTRAK PRO Blood Glucose Monitoring System
- Intended Use: Quantitative measurement of glucose in fresh capillary whole blood (finger, palm, upper-arm, calf, thigh) for healthcare professionals and people with diabetes mellitus at home. Not for diagnosis or screening, and not for neonates. Alternative site testing only during steady-state blood glucose conditions.
- Regulatory Class: Class II
- Regulation Number/Name: 21 CFR 862.1345, Glucose Test System.
- Product Codes: NBW, CGA
- FDA Determination: Substantially Equivalent to a legally marketed predicate device.
To obtain the information you requested, one would typically need to consult the full 510(k) submission, which is often more extensive than the clearance letter provided here.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, rendered in black. The bird is positioned to the right of the text, which is arranged in a circular fashion around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 0 7 2008
TaiDoc Technology Corp. c/o Yuhua Chen Specialist Regulatory Affairs 6F, No. 127, Wugong 2nd Road Wugu Township, Taipei County China (Taiwan) 248
Re: K082618
Trade Name: UltraTRAK PRO Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW, CGA Dated: September 5, 2008 Received: September 9, 2008
Dear Yuhua Chen:
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. Iisting 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 (240) 276-0490. 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 tollit the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.v.M.
Yéan M. Cooper, M.S., D.V.M. 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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Attachment 2
Indications for Use
510(k) Number: K082418
Device Name: UltraTRAK PRO Blood Glucose Monitoring System
Indications for Use:
The UltraTRAK PRO 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 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 UltraTRAK PRO Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Prescription Use (21 CFR Part 801 Subpart D)
Over the Counter Use X And/Or (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 C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082618
Page 1 of 1
§ 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.