GLUCOSE TOLERANCE BEVERAGE

K032753 · Perk Scientific, Inc. · MRV · Nov 18, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032753
• Device Name: GLUCOSE TOLERANCE BEVERAGE
• Applicant: Perk Scientific, Inc.
• Product Code: MRV · Clinical Chemistry
• Decision Date: Nov 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

As an accessory to an In Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and related disease conditions.

Device Story

Glucose Tolerance Beverage is a water-based, flavored beverage containing specific quantities of dextrose. It serves as an accessory to In Vitro Diagnostic Glucose Tolerance Tests. Patients consume the beverage in a supervised clinical setting; healthcare providers subsequently draw blood samples at specified time intervals to measure the body's ability to metabolize glucose. The beverage provides a standardized, pleasant-tasting glucose load to facilitate the diagnostic procedure. It is intended for use in clinical environments where diabetes mellitus or related metabolic conditions are being evaluated.

Clinical Evidence

No clinical data. Bench testing only; independent certification of sugar composition and concentration provided.

Technological Characteristics

Water-based beverage containing dextrose (CAS #50-99-7) and flavoring/preservative agents. Manufactured to WHO and ADA specification ranges. Packaging designed for safety and stability.

Indications for Use

Indicated for patients undergoing an Oral Glucose Tolerance Test to evaluate glucose metabolism, diabetes mellitus, and related conditions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Trutol, Glucose Tolerance Test Beverage (Nerl Diagnostics)

Submission Summary (Full Text)

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# NOV 1 8 2003

K032753

#### Submitter

PERK Scientific, Inc. 520 Commerce Drive Yeadon, PA 19050 Telephone: [phone] Fax: [phone]

# Contact Person

Mark Bartosh President Telephone: [phone] 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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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 [phone]. 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 [phone] or [phone] 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