510(k) · Cleared
ClearedLifescan Onetouch Select / Ultra / Vita Glucose Control Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Feb 10, 2011 as substantially equivalent to K022769 (Bionostics, Inc., 2002) after a 69-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Feb 10, 2011
- Review
- 69 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000318 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK000318 Bionostics Glucose Quality Control Solution for Use with the…Bionostics, Inc. · 2000
- 1 generation backK022769 Lifescan Onetouch Ultra Control SolutionBionostics, Inc. · 2002
- This deviceK103553 Lifescan Onetouch Select / Ultra / Vita Glucose Control SolutionBionostics, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000318 | Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact… | Bionostics, Inc. | 2000 | — |
| −1 | K022769 | Lifescan Onetouch Ultra Control Solution | Bionostics, Inc. | 2002 | — |
| 0 (this device) | K103553 | Lifescan Onetouch Select / Ultra / Vita Glucose Control Solution | Bionostics, Inc. | 2011 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022769 | Lifescan Onetouch Ultra Control SolutionSummary page 1…OneTouch Ultra Control OneTouch Vita Control 510(k), Date: K022769, 11.13.2002 Number of levels: 1, typical fasting glucose 1, typical fasting glucose… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 8.2 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K022769.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (169 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103553 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103553: Lifescan Onetouch Select / Ultra / Vita Glucose Control Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103553
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026