# K011900: Glucose (Hexokinase)

- Pathway: 510(k) (Traditional)
- Applicant: Jas Diagnostics, Inc.
- Decided: Jul 31, 2001 after 43 days
- Product code: CFR (Hexokinase, Glucose)
- 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.
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
- K070704: Trilogy Analyzer (2007), 0 descendants of its own

## Recalls of this device
- Oct 23, 2014 · Class II · Z-0827-2015: Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.
- Apr 7, 2014 · Class II · Z-1873-2014: JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.

## Indications for use
Intended for the In Vitro, quantitative determination of glucose in human serum on automated chemistry analyzers. 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.

Source page: https://510kreport.com/device/K011900
Methodology: https://510kreport.com/methodology