# K022769: Lifescan Onetouch Ultra Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Nov 13, 2002 after 84 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000318 (2000). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000318: Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System, Bionostics, Inc. (2000) Summary page 1.

## Most influential descendants
- K160179: VivaChek Ino Blood Glucose Monitoring System (2017), 4 descendants of its own
- K173140: VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System (2018), 3 descendants of its own
- K111456: Medisign Blood Glucose Monitoring System (2012), 2 descendants of its own
- K233058: VivaChek Link Plus Blood Glucose Monitoring System (2023), 1 descendant of its own
- K243060: TeleRPM Gen2 Blood Glucose Monitoring System (2025), 0 descendants of its own

## Indications for use
LifeScan OneTouch Ultra control solution is intended for use to verify the performance of LifeScan BGM systems using the OneTouch Ultra or OneTouch FastTake test strips at glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

Source page: https://510kreport.com/device/K022769
Methodology: https://510kreport.com/methodology