# K010553: Precision Xtra Blood Glucose Test Strip with Truemeasure Technology

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 18, 2001 after 112 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
No predicates in its family tree.
3 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023256: Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy Blood Glucose Test Strip with True Measure Technolo (2003), 2 descendants of its own
- K051213: Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips (2005), 1 descendant of its own
- K081975: Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS 71030-01 Strips: 7103-01 (20 Count) (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K010553
Methodology: https://510kreport.com/methodology