# K971754: Liquid Glucose (Hexokinase) Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Jul 22, 1997 after 71 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 19, 2009 · Not classified · Z-0104-2010: There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL.

## Indications for use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of glucose in serum or plasma. It is intended for in vitro diagnostic use only. The determination of glucose in serum is most commonly performed for the diagnosis and treatment of diabetes mellitus.

Source page: https://510kreport.com/device/K971754
Methodology: https://510kreport.com/methodology