EasyDeX is a flavored non-carbonated beverage containing specific quantities of dextrose (D-glucose). The manufactured beverages contain three (3) different quantities of glucose; 50, 75, and 100 grams quantities per 10 oz. bottle. This product is used in the administration of an in Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and other related disease conditions. This product is for oral consumption only.

Device Description

EasyDeX is a water-based flavored beverage containing specific quantities of dextrose (d-glucose). The product is manufactured in two (2) flavors (Fruit Punch and Orange) and three (3) concentrations.

AI/ML Overview

This 510(k) submission describes the EasyDeX device, a flavored glucose tolerance beverage. However, the provided document does not contain a study demonstrating the device's performance against specific acceptance criteria in the manner typically expected for a medical device with an AI component or complex diagnostic performance evaluation.

Instead, this submission is for a glucose tolerance drink, which is classified as an in vitro diagnostic (IVD) product. The regulatory review focuses on its composition, manufacturing, and equivalence to a predicate device, rather than on diagnostic accuracy metrics like sensitivity, specificity, or AI performance.

Therefore, many of the requested elements for describing acceptance criteria and a study design (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of device and are not present in the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Primary Acceptance Criteria (Implicit from 510(k) for this type of device):	The device is deemed "as safe, as effective, and performs as well or better than the predicate device."
- Composition and Concentration: The beverage must contain specific quantities of dextrose (d-glucose) as stated for its intended use (50, 75, and 100 grams per 10 oz. bottle).	"EasyDeX is a water-based flavored beverage containing specific quantities of dextrose (d-glucose). The product is manufactured in two (2) flavors (Fruit Punch and Orange) and three (3) concentrations." "The manufactured beverages contain three (3) different quantities of glucose; 50, 75, and 100 grams quantities per 10 oz. bottle." "All products will be tested and certified both in-house and by an independent laboratory for sugar composition and concentration."
- Manufacturing Quality: Manufactured under strict Current Good Manufacturing Practices (cGMP) to specifications set by WHO and ADA.	"The product is manufactured under strict Current Good Manufacturing Practices to the specifications set by the World Health Organization and the American Diabetes Association for this type of product."
- Safety and Effectiveness Equivalence: The device must be as safe and effective as the predicate device (Glucose Tolerance Beverage by Perk Scientific, Inc., K032753).	"This device has the same technological characteristics (composition and packaging) as the predicate device." "The device is as safe, as effective, and performs as well or better than the predicate device."
- Intended Use Equivalence: Used for administration of an in Vitro Diagnostic Glucose Tolerance Test for evaluation of diabetes mellitus and related conditions, for oral consumption.	The Intended Use statement for EasyDeX matches that of a standard glucose tolerance beverage.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document describes a glucose tolerance beverage, not a diagnostic algorithm or device requiring a clinical test set with patient data. The "testing" referred to is for chemical composition and concentration.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this device. The "ground truth" for this product is its chemical composition (glucose concentration), which is verified by laboratory testing.

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

Not Applicable. Adjudication methods are used to resolve discrepancies in expert interpretations of diagnostic data, which is not relevant to this product.

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

Not Applicable. This is not a device with AI components or one that assists human readers.

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

Not Applicable. This is not an algorithm.

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

The "ground truth" for this product is its chemical composition and concentration of dextrose, verified by in-house and independent laboratory testing. This ensures the product delivers the specified amount of glucose as intended.

8. The sample size for the training set

Not Applicable. This is not a machine learning device that requires a training set.

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

Not Applicable.

Summary

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120247

510(k) Summary EasyDeX

JUN 2 1 2012

Submitter

Vineland Syrup Inc. 723 S.E. Blvd. Vineland, New Jersey 08360 Tel.#: 856-691-5772 Fax#: 856-691-0359

Contact Person

Meilech Kornbluh President Tel.#: 856-691-5772 Email: quick@vinelandsyrup.com

Date of Summary Submission

January 23, 2012

Device Identification

Trade Name: EasyDeX Device Name: Drink, Glucose Tolerance Classification: II Product Code: MRV Regulation #: 862.1345

Device to Which Substantial Equivalence is Claimed

Glucose Tolerance Beverage Perk Scientific, Inc. 520 Commerce Dr. Yeadon, PA 19050 510(k) Number: K032753

Device Description

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Intended Use

EasyDex is a flavored non-carbonated beverage containing specific quantities of dextrose (D-glucose). The manufactured beverages contain three (3) different quantities of glucose; 50, 75, and 100 grams quantities per 10 oz. bottle. This product is used in the administration of an in Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and other related disease conditions. This product is for oral consumption only.

Performance Summary

This device has the same technological characteristics (composition and packaging) as the predicate device. The product is manufactured under strict Current Good Manufacturing Practices to the specifications set by the World Health Organization and the American Diabetes Association for this type of product. All products will be tested and certified both in-house and by an independent laboratory for sugar composition and concentration. The device is as safe, as effective, and performs as well or better than the predicate device.

The above statements contain information that is covered in the main body of the 510(k) and does not contain unsubstantiated labeling claims, does not contain trade secrets or confidential commercial information.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract representation of the human form.

10903 New Hampshire Avenue Silver Spring, MD 20993

JUN 2 1 2012

Vineland Syrup, Inc c/o Eric Feerst 57 Hartford Road Sewell, NJ 08080

K120247 Re: Trade Name: EasyDeX

Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: MRV Dated: April 20, 2012 Received: April 26, 2012

Dear Mr. Feerst:

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. of the recording in other Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 Joa attact from Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...

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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

K120247 510(k) Number (if known):

EasyDeX Device Name: · · · · · ·

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

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

Ruta chine.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120247

Page 1 of _

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.