# K972473: One Touch II Hospital Blood Glucose Monitoring System Data Dock

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Dec 16, 1997 after 168 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 its predicate without a number.
- (no number) ONE TOUCH II Hospital Blood Glucose Monitoring System: named in the summary without a submission number

## Indications for use
The ONE ToucH® I HOSPITAL Blood Glucose Monitoring System, consisting of the ONE ToucH® I Hospital Meter, ONE TOUCH® Test Strips, control solutions, data management software, the optional DataDock and other 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 or 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/K972473
Methodology: https://510kreport.com/methodology