# K152328: FreeStyle InsuLinx Blood Glucose Monotioring System

- Pathway: 510(k) (Special)
- Applicant: Abott Laboratories
- Decided: Sep 17, 2015 after 30 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- 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: 7 generations back to K945887 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120568: Freestyle Insulinx Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2012) Summary page 4.

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

Source page: https://510kreport.com/device/K152328
Methodology: https://510kreport.com/methodology