# K153201: SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Sd Biosensor
- Decided: Jun 24, 2016 after 233 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: 4 generations back to K024194 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132929: SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor NFC Blood Glucose Monitoring System, Sd Biosensor, Inc. (2015) Summary page 6.

## Indications for use
SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii®Mentor BT Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The SD GlucoNavii®Mentor BT Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii®Mentor BT Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii®Mentor BT Blood Glucose Test Strips are for use with SD GlucoNavii®Mentor BT Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. SD GlucoNavii®Mentor BT Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoNavii®Mentor BT Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The SD GlucoNavii®Mentor BT Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii®Mentor BT Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii®Mentor BT Multi Blood Glucose Test Strips are for use with SD GlucoNavii®Mentor BT Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

Source page: https://510kreport.com/device/K153201
Methodology: https://510kreport.com/methodology