# K081975: Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS 71030-01 Strips: 7103-01 (20 Count)

- Pathway: 510(k) (Special)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Nov 26, 2008 after 138 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010553 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051213: Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips, Abbott Laboratories, Inc. (2005) Summary page 2.

## Recalls of this device
- Nov 14, 2019 · Class II · Z-1557-2020: Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple
- Dec 22, 2010 · Not classified · Z-0995-2011: Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results.

## Indications for use
The ReliOn Ultima Advance Blood Glucose Monitoring System is intended for in-vitro diagnostic use in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. It is not intended to be used for testing neonatal blood samples. The ReliOn Ultima Advance system is indicated for home (lay user) or professional use in the management of patients with diabetes.

Source page: https://510kreport.com/device/K081975
Methodology: https://510kreport.com/methodology