# K103553: Lifescan Onetouch Select / Ultra / Vita Glucose Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Feb 10, 2011 after 69 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: 2 generations back to K000318 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022769: Lifescan Onetouch Ultra Control Solution, Bionostics, Inc. (2002) Summary page 1.

## Indications for use
The LifeScan OneTouch Select Control Solution is intended for use to verify the performance of the LifeScan OneTouch Select blood glucose monitoring test system at a glucose level printed on the test strip vial. The LifeScan OneTouch Select Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home. The LifeScan OneTouch Ultra Control Solution is intended for use to verify the performance of the LifeScan OneTouch Ultra Family and the OneTouch PingTM Meter Remote blood glucose monitoring test systems at a glucose level printed on the test strip vial. The LifeScan OneTouch Ultra Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home. The LifeScan OneTouch Vita Control Solution is intended for use to verify the performance of the LifeScan OneTouch Vita blood glucose monitoring test system at a glucose level printed on the test strip vial. The LifeScan OneTouch Vita Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

Source page: https://510kreport.com/device/K103553
Methodology: https://510kreport.com/methodology