# K032029: BTG Smartest Glucose Test System

- Pathway: 510(k) (Traditional)
- Applicant: Bt Medical
- Decided: Dec 18, 2003 after 170 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: 1 generation back to K991242 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991242: Glucometer Elite Test Strips, Bayer Corp. (1999) Summary page 1.

## Indications for use
The BTg Smartest Glucose test system is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Source page: https://510kreport.com/device/K032029
Methodology: https://510kreport.com/methodology