510(k) · Cleared
ClearedLiberty Normal Glucose Control Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liberty Healthcare Group, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Apr 28, 2006 as substantially equivalent to K001427 (Selfcare, Inc., 2000) and 2 other predicates after a 43-day review. Its family tree reaches back 6 generations to 1995. 8 later devices descend from it.
- Decided
- Apr 28, 2006
- Review
- 43 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K945887 (1995). 14 ancestors in all, the oldest K850368 (1985). 8 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 5 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 4 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 3 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 2 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 1 generation backK052980 Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
- This deviceK060706 Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK070506 SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK081403 Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK123851 Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK082395 Glucose Meter-Check Control Solution for Bayer Ascensia Blood…Bionostics, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK081915 FDTX Glucose Control SolutionFujirebio Diagnostics Texas, Inc. · 2008
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K070506SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007 · cites it directly5descendants
- K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008 · 2 generations on2descendants
- K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013 · 3 generations on1descendant
- K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc. · 2008 · 2 generations on1descendant
- K081915FDTX Glucose Control SolutionFujirebio Diagnostics Texas, Inc. · 2008 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −5 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −4 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −3 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −2 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −1 | K052980 | Liberty Glucose Control, Model 2120031 | Liberty Healthcare Group, Inc. | 2005 | — |
| 0 (this device) | K060706 | Liberty Normal Glucose Control Solution | Liberty Healthcare Group, Inc. | 2006 | — |
| +1 | K070506 | SMS Multi Glucose Control, Model 2120049 | Medical Specialties Supply Co., Inc. | 2007 | — |
| +2 | K081403 | Glucose Meter-Check Control Solution for Roche Accu-Chek | Bionostics, Inc. | 2008 | — |
| +3 | K123851 | Glucose Meter-Check Solution for Roche Accu-Chek | Bionostics, Inc. | 2013 | — |
| +2 | K082395 | Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter… | Bionostics, Inc. | 2008 | — |
| +1 | K081915 | FDTX Glucose Control Solution | Fujirebio Diagnostics Texas, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001427 | Modification to Fasttake Compact Blood Glucose Monitoring SystemSummary page 1…OneTouch Ultra Control Solution Manufacturer: LifeScan, Inc. 510(k) No.: K001427 Name: Ascensia Microfill Control… | 2000 |
| Kept off the family tree | K023657 | Ascensia Microfill Control Solution Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…Solution Manufacturer: Bayer Healthcare 510(k) No.: K023657 Page 13 of 62 510(k) Premarket Notification: Liberty Normal Glucose Con… | |
| * | K011738 | Accu-Chek Active SystemSummary page 2…l Manufacturer: Roche Diagnostics Corporation 510(k) No.: K011738 Name: Liberty Glucose Control… | 2001 |
| * | K052980 | Liberty Glucose Control, Model 2120031Summary page 2…Manufacturer: Liberty Healthcare Group, Inc. 510(k) No.: K052980 Device Description: The Liberty Normal Glucose Control consists of a vi… | 2005 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K070506 (Medical Specialties Supply Co., Inc., 2007) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K001427.
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.
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?
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals
and in the home by people with diabetes mellitus to assess the performance of
the Roche Accu-chek Active, the Bayer Ascensia Microfill, and the LifeScan
OneTouch Ultra and FastTake Blood Glucose Monitors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060706: Liberty Normal Glucose Control Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060706
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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