510(k) Report

510(k) · Cleared

Cleared

Lifescan Onetouch Ultra Control Solution

K022769510(k) TraditionalCleared Nov 13, 200284-day reviewClass I21 CFR 862.1660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bionostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Nov 13, 2002 as substantially equivalent to K000318 (Bionostics, Inc., 2000) after an 84-day review. Its family tree reaches back 1 generation to 2000. 9 later devices descend from it.

Decided
Nov 13, 2002
Review
84 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K000318 (2000). 9 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2011: 1 descendant cleared2017: 2 descendants cleared2014: 1 descendant cleared2018: 1 descendant cleared2023: 2 descendants cleared2025: 1 descendant clearedK000318 · Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System · Bionostics, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K000318 · Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System · Bionostics, Inc. · 20000
  1. Root · 1 generation backK000318 Bionostics Glucose Quality Control Solution for Use with the…Bionostics, Inc. · 2000
  2. This deviceK022769 Lifescan Onetouch Ultra Control SolutionBionostics, Inc. · 2002
  3. Descendant · cites it directly · 4 of its ownK160179 VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc. · 2017
  4. Descendant · 2 generations on · 3 of its ownK173140 VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino…Vivachek Laboratories, Inc. · 2018
  5. Descendant · cites it directly · 2 of its ownK111456 Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2012
  6. Descendant · 3 generations on · 1 of its ownK233058 VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd. · 2023
  7. Descendant · 4 generations on · 0 of its ownK243060 TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd. · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12014: 12017: 22018: 12023: 22025: 1
2011high 2 (2017) · low 0 (2013)2026

Most influential descendants

Showing 5 of 9 · See all
  • K160179VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc. · 2017 · cites it directly4descendants
  • K173140VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose…Vivachek Laboratories, Inc. · 2018 · 2 generations on3descendants
  • K111456Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2012 · cites it directly2descendants
  • K233058VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd. · 2023 · 3 generations on1descendant
  • K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000318Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact…Bionostics, Inc.2000—
0 (this device)K022769Lifescan Onetouch Ultra Control SolutionBionostics, Inc.2002—
+1K160179VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc.2017—
+2K173140VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood…Vivachek Laboratories, Inc.2018—
+1K111456Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd.2012—
+3K233058VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.2023—
+4K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201410
201720
201810
202320
202510
FIG. 1 — Lineage of K022769, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K000318Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood…
Summary page 1
…Substantial Equivalence There has been no change in formulation, labeling or intended use of the control solution since the original 510(k)submission, K000318. The purpose of this 510(k) submission is to extend the use of this control to all LifeScan family of meters using…
Bionostics, Inc.2000—

Also cleared against K000318: 1 other device →

What descends from it? (9)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K160179VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc.20174
K111456Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd.20122
K103553Lifescan Onetouch Select / Ultra / Vita Glucose Control SolutionBionostics, Inc.20110

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?

  • Its one ancestor has no recall.
  • Of its descendants, K160179 (Vivachek Laboratories, Inc., 2017) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K000318.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007: 62008: 82009: 172010: 242011: 192012: 152013: 192014: 222015: 112016: 62017: 2
2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007: 53 days median2008: 52 days median2009: 80 days median2010: 80 days median2011: 62 days median2012: 40 days median2013: 37 days median2014: 30 days median2015: 65 days median2016: 31 days median
2007high 80 (2009) · low 30 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJX

1in 2021

2007: 32008: 32010: 32011: 22014: 12015: 12016: 22018: 22021: 1
2007high 3 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJX

22in 2025

2007: 22009: 12010: 62011: 622012: 322013: 512014: 482015: 672016: 372017: 192018: 352019: 822020: 772021: 432022: 242023: 222024: 302025: 22
2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200765332
200885230
2009178001
2010248036
20111962262
20121540032
20131937051
20142230148
20151165167
2016631237
20172—019
20180—235
20190—082
20200—077
20210—143
20220—024
20230—022
20240—030
20250—022
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K000318

1 other device cites the same predicate.

  • K013147Glucose Control Solution for Therasense FreestyleBionostics, Inc. · 20011 recall

More from Bionostics, Inc.

49 FDA decisions under this applicant name. See the company

  • K131136Glucose Meter-Check Solution for TaidocBionostics, Inc. · 2013
  • K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013
  • K123966Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013
  • K113764Glucose Meter-Check Solution for InfopiaBionostics, Inc. · 2012
  • K112352Glucose Meter-Check Control for Nipro TrueresultBionostics, Inc. · 2011

Recent decisions in JJX

The JJX category page

  • K170678Beta-CrossLaps CalCheck 5Roche Diagnostics · 2017
  • K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics · 2017
  • K162514Multichem A1cTechnopath Manufacturing · 2016
  • K161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd. · 2016
  • K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016

https://510kreport.com/device/K022769 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022769: Lifescan Onetouch Ultra Control Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022769

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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