# K093789: Intouch Diabetes

- Pathway: 510(k) (Traditional)
- Applicant: Symcare Personalized Health Solutions, Inc.
- Decided: Feb 19, 2010 after 72 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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: 9 generations back to K864318 (1987). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083263: Symcare Diabetes Management Program, Symcare Personalized Health Solutions, Inc. (2009) Summary page 1.
- K073699: MCT-Diabetes, Mycare Team, Inc. (2008) Summary page 1.
- K061328: Think Positive Diabetes Management System (T+Diabetes System), E-San Limited (2006) Summary page 1.

## Indications for use
InTouch™-diabetes is intended for use in home settings to aid people with diabetes and healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data management capabilities. This system is intended for use by people 18 years of age and older. InTouch™-diabetes is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Source page: https://510kreport.com/device/K093789
Methodology: https://510kreport.com/methodology