# K014139: Diabetes Assistant Software

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 21, 2002 after 94 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) Camit Diabetes Management Software: named in the summary without a submission number

## Indications for use
The software is intended to assist health care professional and people with diabetes review and analyze blood glucose test results. The device is not intended to provide any diagnosis on patient results.

Source page: https://510kreport.com/device/K014139
Methodology: https://510kreport.com/methodology