# K120183: Advocate Redi-Code+BMB-EA001S Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Broadmaster Biotech Corperation
- Decided: May 11, 2012 after 109 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K072039 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102316: Glucose Shepherd Blood Glucose Monitoring System, Broadmaster Biotech Corporation (2011) Summary page 3.

## Recalls of this device
- May 5, 2014 · Class I · Z-2021-2014: "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips".

## Indications for use
ADVOCATE® Redi-Code+ BMB-EAOO IS 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 aim, the calf, and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The ADVOCATE® Redi-Code~ BMB-EAOO1 S Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In additional, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control programn. It should not be used for the diagnosis of diabetes, or for the testing of neonates. The ADVOCATE®0 Redi-Code+ BMB-EAOO 1S Blood Glucose Monitoring Systems consists of the ADVOCATE® Redi-Code+ BMB-EAOOlIS Blood Glucose meter and the AD VOCATE® Redi-Code+ BMB-BAOO6A Blood Glucose test strips. The ADVOCATE® Redi-Code+ BMB-EAOOI S meter are used only with ADVOCATE® Redi-Code+ BMB-BA006A 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 meter also included speaking functions but has not been validated for use by the visually impaired. The ADVOCATE® Redi-Code+ control solutions are for use with the ADVOCATE® Redi-Code+ BMIB-EAOO1 S Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K120183
Methodology: https://510kreport.com/methodology