# K051213: Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories, Inc.
- Decided: May 27, 2005 after 15 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010553 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023256: Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy Blood Glucose Test Strip with True Measure Technolo, Abbott Laboratories (2003) Summary page 2.

## Most influential descendants
- K081975: Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS 71030-01 Strips: 7103-01 (20 Count) (2008), 0 descendants of its own

## Recalls of this device
- Dec 22, 2010 · Not classified · Z-0996-2011: 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.
- Dec 22, 2010 · Not classified · Z-0999-2011: 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.
- Dec 22, 2010 · Not classified · Z-0997-2011: 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 Precision Xtra / MediSense Optium / Precision Easy / MediSense Optium Easy Blood Glucose Test Strip is intended for outside-the-body (in-vitro diagnostic) use. The strip is indicated for the quantitative measurement of glucose in fresh capillary blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. The test strip is to be used for monitoring blood glucose concentrations in persons with diabetes and other conditions.

Source page: https://510kreport.com/device/K051213
Methodology: https://510kreport.com/methodology