# K102316: Glucose Shepherd Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Broadmaster Biotech Corporation
- Decided: Oct 7, 2011 after 417 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 K072039 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072039: Advocate Redi-Code Blood Glucose Monitoring System, Models TD-4223E; TD-4223F, Taidoc Technology Corporation (2007) Summary page 1.

## Most influential descendants
- K120183: Advocate Redi-Code+BMB-EA001S Blood Glucose Monitoring System (2012), 0 descendants of its own

## Indications for use
Glucose Shepherd Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates. The Glucose Shepherd Blood Glucose Monitoring System consists of the Glucose Shepherd Blood Glucose meter and the Glucose Shepherd Blood Glucose test strips. The Glucose Shepherd Blood Glucose meter is used only with Glucose Shepherd Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh. The Glucose Shepherd Control Solutions are for use with the Glucose Shepherd Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results. Glucose Shepherd Pro Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use), It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the uipper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Pro Blood Glucose Monitoring System may be used for multiple patients in a professional healthcare setting. It is intended for use as an aid in monitoring the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing devices. it should not be used for the diagnosis or screening of diabetes, for the testing of neonates, or for testing of arterial blood. The Glucose Shepherd Pro Blood Glucose Monitoring System consists of the Glucose Shepherd Pro Blood Glucose meter and the Glucose Shepherd Pro Blood Glucose test strips. The Glucose Shepherd Pro Blood Glucose meter is used only with Glucose Shepherd Pro Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh. The Glucose Shepherd Pro control solutions are for use with the Glucose Shepherd Pro Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K102316
Methodology: https://510kreport.com/methodology