# K050985: Glucodr Supersensor System

- Pathway: 510(k) (Traditional)
- Applicant: All Medicus Co., Ltd.
- Decided: Oct 7, 2005 after 171 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 K032552 (2003). 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)
- K032552: Accu-Chek Advantage System, Roche Diagnostics Corp. (2003) Summary page 1.

## Indications for use
The GlucoDrTM SuperSensor system is intended for in vitro diagnostic use (i. e., for external use only) for quantitative measurement of glucose in venous whole blood and capillary whole blood from the fingertip. The GlucoDr TmSuperSensor system may be used by healthcare professionals or for self testing by diabetic lay users in the home. The GlucoDr TM SuperSensor system is not intended for the diagnosis of or screening for diabetes mellitus. The GlucoDr TM SuperSensor system is not intended for use on neonates.

Source page: https://510kreport.com/device/K050985
Methodology: https://510kreport.com/methodology