# K083628: Glucodr Auto System

- Pathway: 510(k) (Traditional)
- Applicant: All Medicus Co., Ltd.
- Decided: May 1, 2009 after 144 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: 2 generations back to K010362 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043474: Accu-Chek Aviva System, Roche Diagnostics Corp. (2005) Summary page 1.

## Most influential descendants
- K170241: GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System (2017), 0 descendants of its own

## Indications for use
The GlucoDr TM auto blood glucose monitoring system is intended for in vitro diagnostic use (i.e., for external use only) for quantitative measurement of glucose in venous, arterial and capillary whole blood. Testing sites include traditional fingertip site along with palm, upper arm, forearm, thigh, and calf. The GlucoDr TM auto blood glucose monitoring system may be used by healthcare professionals or for self testing by diabetic lay users in the mellitus at home as aid in monitoring the effectiveness of diabetes control program. The GlucoDr TM auto blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. The GlucoDr TM auto control solution is for use with the the GlucoDrTM auto test meters and strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K083628
Methodology: https://510kreport.com/methodology