# K050182: Q.Steps Biometer G/C Dual Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Biomedix, Inc.
- Decided: Aug 9, 2005 after 194 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: 2 generations back to K990688 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033627: Q.Steps Biometer G Blood Glucose Monitoring System, Biomedix, Inc. (2004) Summary page 2.
- K023558: PTS Panels Lipid Panel Test Strips, Polymer Technology Systems, Inc. (2002) Summary page 2.
- K031472: One Touch Basic/Profile/One Touch II Test Strips, Lifescan, Inc. (2003) Summary page 2.

## Indications for use
The Q.STEPS Biometer G/C Dual Monitoring System is intended for use with Q.STEPS Glucose and Cholesterol Test Strips with Q.STEPS Biometer G/C by healthcare professionals and home users. Q.STEPS Biometer G/C System provides a quantitative measurement of Glucose and Cholesterol in whole blood from the fingertips. The Glucose measurements are used in helping the management of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors. Cholesterol measurements are used in the management of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders.

Source page: https://510kreport.com/device/K050182
Methodology: https://510kreport.com/methodology