# K980026: Glucose (HK) - Incorporating Dynamic Stabilization Technology - (DST)

- Pathway: 510(k) (Traditional)
- Applicant: Trace America, Inc.
- Decided: Mar 10, 1998 after 64 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K984574: Infinity Glucose Reagent (1999), 0 descendants of its own

## Indications for use
Intended for the In Vitro, quantitative determination of Glucose in human serum, plasma urine. This "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". CFR862.1345

Source page: https://510kreport.com/device/K980026
Methodology: https://510kreport.com/methodology