# K161834: One Drop Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Agamatrix, Inc.
- Decided: Nov 30, 2016 after 148 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: 6 generations back to K952279 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152365: AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System, Agamatrix, Inc. (2016) Summary page 4.

## Indications for use
The One Drop Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop 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 One Drop Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates. The One Drop Blood Glucose Test Strips: The One Drop Blood Glucose Test Strips are for use with the One Drop Blood Glucose Meter to quantitatively measure blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Source page: https://510kreport.com/device/K161834
Methodology: https://510kreport.com/methodology