# K984527: IN Touch Diabetes Management Software

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Apr 29, 1999 after 129 days
- Product code: CGA (Glucose Oxidase, 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.
55 later devices descend from it; 6 cite it directly.
0 of 56 devices 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) LifeScan ONE TOUCH® Profile® Diabetes Tracking System: named in the summary without a submission number
- (no number) MediSense® Precision Link™ Blood Glucose Data Management System: named in the summary without a submission number

## Most influential descendants
- K040086: Health Buddy with Buddylink (2004), 47 descendants of its own
- K042273: Modification to Health Buddy with Device Connectivity (2004), 45 descendants of its own
- K050567: Health Buddy Appliance (2005), 40 descendants of its own
- K060843: Modification to Health Buddy Appliance (2006), 39 descendants of its own
- K063612: Modification to Health Buddy Appliance (2006), 30 descendants of its own

## Recalls of this device
- Dec 18, 2007 · Not classified · Z-1317-2008: Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.

## Indications for use
The IN TOUCH Diabetes Management Software System is intended for use in home and clinical settings to aid people with diabetes and health care 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 LifeScan Brand blood glucose monitoring systems with data management capabilities.

Source page: https://510kreport.com/device/K984527
Methodology: https://510kreport.com/methodology