# K062118: Pointe 360

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Jul 13, 2007 after 353 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
Longest line of descent: 1 generation back to K953847 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953847: Roche Reagent for Glucose, Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Indications for use
The Glucose Hexokinase reagent set is intended to be used in a diagnostic laboratory setting by qualified laboratory technologists for the quantitative determination of glucose in human serum and plasma on the Pointe 360 Analyzer. It is for In Vitro diagnostic use only. The determination of glucose in serum and plasma is for use in the diagnosis and treatment of diabetes mellitus.

Source page: https://510kreport.com/device/K062118
Methodology: https://510kreport.com/methodology