# K082328: Glucodr Plus System, Model Agm-3000

- Pathway: 510(k) (Traditional)
- Applicant: All Medicus Co., Ltd.
- Decided: Feb 27, 2009 after 197 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The GlucoDrTM Plus 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. Testing sites include traditional fingertip site along with palm, arm and thigh. The GlucoDrTM Plus system may be used by healthcare professionals or for self testing by diabetic lay users with diabetes mellitus at home as aid in monitoring the effectiveness of diabetes control program. The GlucoDrTM Plus system is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. The GlucoDrTM Plus control solution is for use with the The GlucoDrTM Plus meters and strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K082328
Methodology: https://510kreport.com/methodology