GLUCOSE TOLERANCE BEVERAGE

K042183 · Ever Scientific · MRV · Oct 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042183
• Device Name: GLUCOSE TOLERANCE BEVERAGE
• Applicant: Ever Scientific
• Product Code: MRV · Clinical Chemistry
• Decision Date: Oct 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The intended use is as an accessory to an In Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and related disease conditions.

Device Story

Glucose Drink is a flavored, non-carbonated, water-based beverage containing precise quantities of D-glucose (50g, 75g, or 100g per 10 oz bottle). It serves as an accessory for In Vitro Diagnostic Glucose Tolerance Tests. Patients consume the beverage as part of a clinical diagnostic procedure to assess glucose metabolism. Healthcare providers use the resulting blood glucose measurements to evaluate patients for diabetes mellitus and related conditions. The device provides a standardized glucose load to ensure consistent diagnostic testing.

Clinical Evidence

No clinical data. Performance is supported by bench testing, including independent certification of sugar composition and concentration, and shelf-life stability testing.

Technological Characteristics

Water-based, non-carbonated flavored beverage containing D-glucose. Available in 50g, 75g, and 100g concentrations per 10 oz bottle. Manufactured according to WHO and ADA specifications. Subject to GMP requirements.

Indications for Use

Indicated for use in patients undergoing an In Vitro Diagnostic Glucose Tolerance Test to detect glucose intolerance and evaluate diabetes mellitus and related illnesses. Available in 50, 75, and 100 gram dextrose concentrations.

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

• GTB, Glucose Tolerance Beverage (Perk Scientific, Inc.)

Submission Summary (Full Text)

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# OCT 27 2004

K042183

# 510K Summary of Safety and Effectiveness - Glucose Drink

#### Submitter

EverScientific, Inc. 7 Wetherill Lane Chester Springs, PA 19425

#### Contact Person

Jay Reinhardt Telephone: [phone] Email: [e-mail]

#### Date of Summary Preparation

04/19/04

# 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

GTB, Glucose Tolerance Beverage Perk Scientific, Inc., Yeadon, PA

# Description of Device

Glucose Drink is a water-based non-carbonated flavored beverage containing specific quantities of dextrose. We are marketing three flavors; orange, fruit punch, and lemonlime. Each flavor will have glucose concentrations of 50, 75, 100 grams of D-glucose per 10 oz bottle.

#### Intended Use

The intended use is as an accessory to an In Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and related disease conditions.

#### Performance Summarv

Glucose Drink 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. Additionally shelf life stability testing will be completed prior to marketing product.

# Conclusion

Glucose Drink has the same intended use and characteristics as the predicate device.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 7 2004

Mr. Jay Reinhardt Vice President of Product Development Ever Scientific 7 Wetherill Lane Chester Springs, PA 19425

Re: k042183 Trade/Device Name: Glucose Drink Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: MRV Dated: July 28, 2004 Received: August 11, 2004

Dear Mr. Reinhardt:

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,

Jean M. Cooper US. Div.

Jean M. Cooper, MS, 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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# Indications for Use

510(k) Number (if known): K042183

Device Name: Glucose Drink

Indications For Use: Glucose Drink is a flavored beverage containing specific amounts of dextrose (D-glucose). Manufactured beverages contain three different amounts of glucose; 50,75, and 100 grams quantities per 10 oz bottle. This product is consumed in the In Vitro Diagnostic Glucose Tolerance Test for the detection of glucose intolerance in the evaluation of diabetes mellitus and other related illnesses.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alle & Curz
Division Sign Off

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042183