# K173658: Confidence Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Biomedical, LLC
- Decided: Aug 21, 2018 after 265 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: 5 generations back to K053529 (2006). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150214: OneTouch Verio Flex Blood Glucose Monitoring System, Lifescan Europe (2015) Summary page 4.

## Indications for use
The Confidence Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The Confidence Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Confidence Blood Glucose Monitoring System 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 Confidence Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The Confidence Blood Glucose Test Strips are for use with the Confidence Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

Source page: https://510kreport.com/device/K173658
Methodology: https://510kreport.com/methodology