510(k) Report

510(k) · Cleared

Cleared

Liberty Glucose Control, Model 2120031

K052980510(k) TraditionalCleared Nov 30, 200537-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

Liberty Healthcare Group, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Nov 30, 2005 as substantially equivalent to K983504 (Medisense, Inc., 1999) after a 37-day review. Its family tree reaches back 5 generations to 1995. 19 later devices descend from it.

Decided
Nov 30, 2005
Review
37 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K945887 (1995). 11 ancestors in all, the oldest K850368 (1985). 19 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1991: 1 other ancestor1985: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1990: 1 other ancestor2006: 3 descendants cleared2007: 4 descendants cleared2008: 5 descendants cleared2009: 2 descendants cleared2010: 1 descendant cleared2013: 2 descendants cleared2011: 1 descendant cleared2016: 1 descendant clearedK945887 · Precision Q I D Blood Glucose Test Strips · Medisense, Inc. · 1995K962295 · Precision Qid Blood Glucose Test Strip · Medisense, Inc. · 1996K963676 · Precision G Blood Glucose Testing System · Medisense, Inc. · 1997K971812 · Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip · Medisense, Inc. · 1997K983504 · Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST · Medisense, Inc. · 1999 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 4 other ancestors 1 generation forward: 5 descendants2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K983504 · Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST · Medisense, Inc. · 1999 · recalledK971812 · Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip · Medisense, Inc. · 1997K963676 · Precision G Blood Glucose Testing System · Medisense, Inc. · 1997K962295 · Precision Qid Blood Glucose Test Strip · Medisense, Inc. · 1996K945887 · Precision Q I D Blood Glucose Test Strips · Medisense, Inc. · 1995−50+5
  1. Root · 5 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
  2. 4 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
  3. 3 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
  4. 2 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
  5. 1 generation backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
  6. This deviceK052980 Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
  7. Descendant · cites it directly · 8 of its ownK060706 Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
  8. Descendant · 2 generations on · 5 of its ownK070506 SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007
  9. Descendant · cites it directly · 4 of its ownK060481 Liberty Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
  10. Descendant · 2 generations on · 2 of its ownK083549 Abt Glucose Control SolutionAmerican Biological Technologies, Inc. · 2008
  11. Descendant · 3 generations on · 2 of its ownK081403 Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2006: 32007: 42008: 52009: 22010: 12011: 12013: 22016: 1
2006high 5 (2008) · low 0 (2012)2026

Most influential descendants

Showing 5 of 19 · See all
  • K060706Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006 · cites it directly8descendants
  • K070506SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007 · 2 generations on5descendants
  • K060481Liberty Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006 · cites it directly4descendants
  • K083549Abt Glucose Control SolutionAmerican Biological Technologies, Inc. · 2008 · 2 generations on2descendants
  • K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K945887Precision Q I D Blood Glucose Test StripsMedisense, Inc.1995—
−4K962295Precision Qid Blood Glucose Test StripMedisense, Inc.1996—
−3K963676Precision G Blood Glucose Testing SystemMedisense, Inc.1997—
−2K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc.1997—
−1K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose…Medisense, Inc.19991
0 (this device)K052980Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc.2005—
+1K060706Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc.2006—
+2K070506SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc.2007—
+1K060481Liberty Glucose Control SolutionLiberty Healthcare Group, Inc.2006—
+2K083549Abt Glucose Control SolutionAmerican Biological Technologies, Inc.2008—
+3K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199010
199110
199520
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200740
200850
200920
201010
201110
201320
201610
FIG. 1 — Lineage of K052980, 1995–2016Source: 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips…
Summary page 1
…r: Abbott Laboratories, Inc. Medisense Products 510(k) No.: K983504 Device Description: The Liberty Glucose Control MID consists of a viscosity- adjuste…
Medisense, Inc.19991

Also cleared against K983504: 5 other devices →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K060706Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc.20068
K060481Liberty Glucose Control SolutionLiberty Healthcare Group, Inc.20064
K063855Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution…Liberty Healthcare Group, Inc.20071
K060426Liberty Glucose Normal Control Solutions, Model 2120041Liberty Healthcare Group, Inc.20061
K070649SMS Glucose Control, Model 2120061Spectrum Medical Supply, Inc.20070

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 10 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K060706 (Liberty Healthcare Group, Inc., 2006) has gone furthest, with 8 descendants of its own.
  • 5 other devices also cite its predicate K983504.

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?

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 Medisense Optium, Precision, Precision 3, and Precision Xtra Blood Glucose Monitors.

Indications for use as stated in the FDA summary.

Also cleared against K983504

5 other devices cite the same predicate.

  • K081478Rna Medical Glucose and B-Ketone Calibration Verification ControlsBionostics, Inc. · 2008
  • K060768Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test StripsAbbott Diabetes Care, Inc. · 20061 recall
  • K040814Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 20043 recalls
  • K033845Precision Xceed Diabetes Monitoring SystemAbbott Laboratories · 20042 recalls
  • K012975Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision Control SolutionsAbbott Laboratories · 2002

More from Liberty Healthcare Group, Inc.

5 FDA decisions under this applicant name. See the company

  • K063855Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution, Model 2120047Liberty Healthcare Group, Inc. · 2007
  • K060706Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
  • K060426Liberty Glucose Normal Control Solutions, Model 2120041Liberty Healthcare Group, Inc. · 2006
  • K060481Liberty Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006

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/K052980 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052980: Liberty Glucose Control, Model 2120031.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052980

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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