(74 days)
None
No
The device is a beverage containing dextrose, used as an accessory for a glucose tolerance test. There is no mention of any computational or analytical components that would utilize AI or ML.
No
The device is described as an accessory to an In Vitro Diagnostic Glucose Tolerance Test and does not directly treat or prevent a disease, but rather aids in diagnosis.
No
Justification: The device is described as an "accessory to an In Vitro Diagnostic Glucose Tolerance Test." It is a beverage containing specific quantities of dextrose, used in the evaluation of diabetes mellitus, but it does not perform the diagnosis itself. The diagnostic test would be the one that uses this beverage to then measure glucose levels and interpret the results.
No
The device description clearly states it is a "water-based flavored beverage containing specific quantities of dextrose," which is a physical product, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic) accessory.
Here's why:
- Intended Use: The primary intended use is explicitly stated as "As an accessory to an In Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and related disease conditions." This directly links the beverage to an IVD test.
- Function: The beverage is consumed by the patient to provide a specific, measured dose of glucose, which is a crucial component of the glucose tolerance test. The test itself then measures the body's response to this glucose load, which is an in vitro diagnostic process (analyzing blood or other samples).
- Device Description: While it's a beverage, its composition (specific quantities of dextrose) is designed to be a standardized input for the diagnostic test.
- Predicate Device: The predicate device is also a "Glucose Tolerance Test Beverage," further reinforcing its role as an accessory to an IVD test.
Therefore, even though the beverage itself isn't performing the analysis, its function is integral to the performance of the IVD glucose tolerance test. It's a necessary component for the test to be conducted correctly and provide meaningful diagnostic information.
N/A
Intended Use / Indications for Use
As an accessory to an In Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and related disease conditions.
Product codes
MRV
Device Description
Glucose Tolerance Beverage is a water-based flavored beverage containing specific quantities of dextrose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
supervised setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Glucose Tolerance Beverage and the predicate device are similar with respect to intended use, size and technological characteristics. The product is manufactured using GMP to the specification ranges set by the World Health Organization and American Diabetes Association for such products. All products are independently certified as to the sugar composition and concentration.
Key Metrics
Not Found
Predicate Device(s)
Trutol, Glucose Tolerance Test Beverage
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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NOV 1 8 2003
Submitter
PERK Scientific, Inc. 520 Commerce Drive Yeadon, PA 19050 Telephone: 610-259-1009 Fax: 610-284-4448
Contact Person
Mark Bartosh President Telephone: 610-259-1009 Email: markb(@hydrolchemical.com
Date of Summary Preparation
September 4, 2003
Device Identification
| Product Trade Name: | Glucose Tolerance Beverage |
|---|---|
| Device Name: | Drink, Glucose Tolerance |
| Classification: | II |
| Product Code: | MRV |
| Regulation Number: | 862.1345 |
Device to Which Substantial Equivalence is Claimed
Trutol, Glucose Tolerance Test Beverage Nerl Diagnostics, East Providence, RI Legally marketed prior to May 28, 1976
Description of Device
Glucose Tolerance Beverage is a water-based flavored beverage containing specific quantities of dextrose.
Intended Use
As an accessory to an In Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and related disease conditions.
Performance Summary
Glucose Tolerance Beverage and the predicate device are similar with respect to intended use, size and technological characteristics. The product is manufactured using GMP to the specification ranges set by the World Health Organization and American Diabetes Association for such products. All products are independently certified as to the sugar composition and concentration.
Conclusion
Glucose Tolerance Beverage has the same intended use and characteristics as the predicate device. Moreover, independent testing demonstrates that the technological/packaging advances of the proposed device do not affect the characteristics of the contents and do not raise any new questions of safety or effectiveness. Glucose Tolerance Beverage is safe and packaging performance characteristics are substantially equivalent to or better than the predicate device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine.
NOV 1 8 2003
Food and Drug Administration. 2098 Gaither Road Rockville MD 20850
Mr. Mark Bartosh President PERK Scientific, Inc. 520 Commerce Drive Yeadon, PA 19050
Re: K032753
Trade/Device Name: Glucose Tolerance Beverage Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: MRV Dated: September 4, 2003 Received: September 5, 2003
Dear Mr. Bartosh:
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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Description of Device and Intended Use
Glucose Tolerance Beverage is a water-based flavored beverage with specific amounts of dextrose. The beverage is used as an accessory to an In Vitro Diagnostic Glucose Tolerance Test for the detection of glucose intolerance in the evaluation of diabetes mellitus and related disease conditions. The beverage is consumed by patients in a supervised setting and subsequent blood samples are drawn at specified time intervals. The tests are designed to measure the efficiency of the body to metabolize glucose. All contents other than water and dextrose are used strictly for flavoring and preservative characteristics and do not alter the overall dextrose content.
The proposed glucose tolerance beverage is designed to provide patients a safely packaged and pleasant tasting glucose load for the Oral Glucose Tolerance Test.
Note: Dextrose, CAS #50-99-7, is used interchangeably throughout the registration with Glucose, D-Glucose, Anhydrous Dextrose and Anhydrous Glucose.
Tan Cooper
Division Sign-Off
fice of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032753