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.

Device Description

Glucose Tolerance Beverage is a water-based flavored beverage containing specific quantities of dextrose.

Glucose Tolerance Beverage is a water-based flavored beverage with specific amounts of dextrose.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Glucose Tolerance Beverage". This device is a flavored drink containing dextrose, intended to be used as an accessory for an In Vitro Diagnostic Glucose Tolerance Test. The document is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device (Trutol, Glucose Tolerance Test Beverage).

Based on the information provided in the document, here's a breakdown of the requested criteria, with explanations where information is not present:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Intended Use	The device's intended use is "As an accessory to an In Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and related disease conditions."	The device is substantially equivalent to the predicate device in terms of intended use.
Material/Composition	Flavored beverage containing specific quantities of dextrose.	The document states "All contents other than water and dextrose are used strictly for flavoring and preservative characteristics and do not alter the overall dextrose content."
Manufacturing Standards	Manufactured using GMP to the specification ranges set by the World Health Organization and American Diabetes Association for such products.	Independent certification confirms sugar composition and concentration.
Technological Characteristics	Similar to the predicate device.	The submission argues that "technological/packaging advances of the proposed device do not affect the characteristics of the contents".
Performance (Dextrose Content)	All products are independently certified as to the sugar composition and concentration.	This indicates the device meets established specifications for its active ingredient.
Safety and Effectiveness	The device is safe, and packaging performance characteristics are substantially equivalent to or better than the predicate device.	This is the overall conclusion of the substantial equivalence claim. The premise is that by being substantially equivalent to a device marketed prior to May 28, 1976, its safety and effectiveness are established.

2. Sample size used for the test set and the data provenance

The document does not report specific sample sizes for a test set or data provenance in the context of device performance, as it relies on demonstrating substantial equivalence rather than a clinical performance study with a test set of patient data. The "independent testing" refers to certification of the product's sugar composition and concentration, not a study involving patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable/not provided. The submission does not describe a study involving a test set with expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. There is no described test set or adjudication process.

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

This information is not applicable/not provided. The device is a "Glucose Tolerance Beverage," not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. The device is a consumable component for a diagnostic test, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable/not provided in the context of a clinical study. The "ground truth" for this device's performance relates to its chemical composition and manufacturing adherence to specifications (e.g., precise dextrose content), which are verified through independent certification rather than clinical ground truth measures like pathology or outcomes data.

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable/not provided.

Summary of the "Study" (Performance Summary for Substantial Equivalence):

The "study" presented is not a traditional clinical trial or performance study comparing a new algorithm to human readers. Instead, it is an argument for substantial equivalence to a predicate device. The core of the performance summary states:

"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."

The conclusion is that the device "has the same intended use and characteristics as the predicate device" and that "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."

Therefore, the "proof" the device meets acceptance criteria primarily relies on:

Comparison to a legally marketed predicate device: Demonstrating that the new device has the same intended use and similar technological characteristics.
Adherence to established manufacturing and content standards: Stating that the product is manufactured under Good Manufacturing Practices (GMP) and meets WHO and ADA specifications for glucose tolerance products, with independent certification of its sugar composition.

This approach is typical for 510(k) submissions where a device is deemed substantially equivalent to an existing device rather than requiring de novo clinical efficacy studies.

Summary

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NOV 1 8 2003

K032753

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

Regulation Number and Section

§ 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.