# K033627: Q.Steps Biometer G Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Biomedix, Inc.
- Decided: May 21, 2004 after 184 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
Longest line of descent: 1 generation back to K031472 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031472: One Touch Basic/Profile/One Touch II Test Strips, Lifescan, Inc. (2003)

## Most influential descendants
- K050182: Q.Steps Biometer G/C Dual Monitoring System (2005), 0 descendants of its own

## Indications for use
The Q.STEPS™ Biometer G Blood Glucose Monitoring System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood from the fingertip for all ages (excluding neonates.) It is intended for use outside the body (for in vitro diagnostic use) by health care professionals in settings such as clinical laboratories and physician offices laboratories (POLs) as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K033627
Methodology: https://510kreport.com/methodology