# K042183: Glucose Tolerance Beverage

- Pathway: 510(k) (Traditional)
- Applicant: Ever Scientific
- Decided: Oct 27, 2004 after 77 days
- Product code: MRV (Drink, Glucose Tolerance)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GTB, Glucose Tolerance Beverage: named in the summary without a submission number

## Recalls of this device
- Aug 24, 2016 · Class II · Z-0330-2017: Out of Specification Microbiological test results
- Aug 24, 2016 · Class II · Z-0329-2017: Out of Specification Microbiological test results

## 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.

Source page: https://510kreport.com/device/K042183
Methodology: https://510kreport.com/methodology