# K973676: Prestige Aqueous Glucose Control Low, Prestige Aqueous Glucose Control High

- Pathway: 510(k) (Traditional)
- Applicant: Sorrento Biochemical, Inc.
- Decided: Dec 16, 1997 after 81 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Prestige Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit. Glucose monitoring has become a major adjunct to the care of individuals with diabetes mellitus in the past decade. It is now possible for the individual with diabetes and the health-care professional to measure and record blood glucose levels frequently with portable devices. In the hospital, blood glucose monitor kits are often used instead of routine laboratory glucose testing methods to quickly obtain blood glucose concentrations from patients in the ER, ICU, CCU, OR, or other bedside locations. Used at home, these kits allow individuals with diabetes to monitor and treat fluctuations in blood glucose levels daily.

Source page: https://510kreport.com/device/K973676
Methodology: https://510kreport.com/methodology