# K974451: One Touch II Hospital Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Jan 26, 1998 after 62 days
- Product code: CGA (Glucose Oxidase, 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.
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. The FDA summary names no predicate by number.

## Indications for use
The ONE TOUCH® II Hospital Blood Glucose Monitoring System, consisting of the ONE TOUCH® II Hospital Meter, ONE TOUCH® Test Strips (Hospital Products), control solutions, data management software and other optional accessories is intended for quantitative measurement of glucose in whole blood in hospital, clinic, and home settings. It is intended for monitoring glucose levels in neonatal and non-neonatal whole blood samples. Non-neonatal glucose results can be reported in either whole blood equivalents or plasma/serum equivalents.

Source page: https://510kreport.com/device/K974451
Methodology: https://510kreport.com/methodology