(146 days)
Not Found
No
The device is a glucose tolerance beverage, which is a consumable product used in diagnostic testing, not a software or hardware device that would typically incorporate AI/ML. The description focuses on its composition and manufacturing process.
No.
This device is used for diagnostic purposes (in Vitro Diagnostic Glucose Tolerance Test) and is not intended to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" states, "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 directly indicates its role in diagnosis.
No
The device description clearly states it is a flavored beverage containing dextrose, which is a physical product, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the 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 directly links the product's use to an in vitro diagnostic procedure.
- Function: The product provides a precisely measured dose of glucose, which is a critical component of a glucose tolerance test. This test involves analyzing a biological sample (blood) after the administration of the glucose load to assess the body's ability to process sugar. This process falls under the definition of an in vitro diagnostic test.
While the device itself is a beverage, its intended use and function within the context of a glucose tolerance test classify it as an IVD. It's a reagent or component used in an in vitro diagnostic procedure.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MRV
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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
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.
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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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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:
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.
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
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