# K171941: FreeStyle Precision Neo Blood Glucose Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Sep 27, 2017 after 91 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 Test Strips are for use outside the body only (in vitro diagnostic use) with the FreeStyle Libre Reader’s built-in meter as components of the FreeStyle Libre Flash Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. They are not intended to be used for testing neonatal blood samples or for the diagnosis or screening of diabetes. The FreeStyle Precision Neo Blood Glucose Test Strips are indicated for home (lay) user in the management of patients with diabetes. They are intended to be used by a single person and should not be shared.

Source page: https://510kreport.com/device/K171941
Methodology: https://510kreport.com/methodology