# K142928: FreeStyle Precision Neo Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Sep 30, 2015 after 356 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: 2 generations back to K083223 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140371: Freestyle Precision Neo Blood Glucose: Monitoring System, Test Strips (50CT), Test Strips (100CT), Abbott Diabetes Care, Inc. (2014) Summary page 4.

## Indications for use
The FreeStyle Precision Neo Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes. The FreeStyle Precision Neo System is indicated for home (lay user) in the management of patients with diabetes. It is intended to be used by a single person and should not be shared. The FreeStyle Precision Neo Blood Glucose Test Strips are for use with the FreeStyle Precision Neo Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Source page: https://510kreport.com/device/K142928
Methodology: https://510kreport.com/methodology