510(k) Report

510(k) · Cleared

Cleared

SMS Glucose Control, Model 2120061

K070649510(k) TraditionalCleared Apr 12, 200735-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

Spectrum Medical Supply, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Apr 12, 2007 as substantially equivalent to K030703 (Home Diagnostics, Inc., 2003) and 2 other predicates after a 35-day review. Its family tree reaches back 6 generations to 1995.

Decided
Apr 12, 2007
Review
35 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K945887 (1995). 14 ancestors in all, the oldest K850368 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2003: 1 other ancestor1991: 1 other ancestor1985: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1990: 1 other ancestorK945887 · 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 · recalledK052980 · Liberty Glucose Control, Model 2120031 · Liberty Healthcare Group, Inc. · 200519851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors3 generations back: 2 other ancestors4 generations back: 4 other ancestors K052980 · Liberty Glucose Control, Model 2120031 · Liberty Healthcare Group, Inc. · 2005K983504 · 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
  1. Root · 6 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
  2. 5 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
  3. 4 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
  4. 3 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
  5. 2 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
  6. 1 generation backK052980 Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
  7. This deviceK070649 SMS Glucose Control, Model 2120061Spectrum Medical Supply, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K945887Precision Q I D Blood Glucose Test StripsMedisense, Inc.1995—
−5K962295Precision Qid Blood Glucose Test StripMedisense, Inc.1996—
−4K963676Precision G Blood Glucose Testing SystemMedisense, Inc.1997—
−3K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc.1997—
−2K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose…Medisense, Inc.19991
−1K052980Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc.2005—
0 (this device)K070649SMS Glucose Control, Model 2120061Spectrum Medical Supply, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199010
199110
199520
199610
200310
200410
FIG. 1 — Lineage of K070649, 1995–2007Source: 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.

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  • 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? (3)

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
*K030703Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood Glucose…
Summary page 1
…and unassayed). Class | per 21 CFR 862.1660 75 JJX Chemistry Name: TrueTrack Smart System Glucose Control Level 0 Manufacturer: Home Diagnostics, Inc. 510(k) No.: K030703 Name: TrackEASE Smart System Glucose Control Level O Manufacturer: Home Diagnostics, Inc. 510(k) No.: K042080 Page 9 of 40 =…
Home Diagnostics, Inc.20032
*K042080Trackease Smart System Blood Glucose System
Summary page 1
…vel 0 Manufacturer: Home Diagnostics, Inc. 510(k) No.: K030703 Name: TrackEASE Smart System Glucose Control Level O Manufacturer: Home Diagnostics, Inc. 510(k) No.: K042080 Page 9 of 40 510(k) Premarket Notification: SMS Glucose Control American Biological Technologies, Inc. Name: Li…
Home Diagnostics, Inc.20041
*K052980Liberty Glucose Control, Model 2120031
Summary page 2
…market Notification: SMS Glucose Control American Biological Technologies, Inc. Name: Liberty Glucose Control - Manufacturer: Liberty Healthcare Group, Inc. 510(k) No.: K052980 Device Description: The SMS Glucose Control consists of a viscosity- adjusted, aqueous liquid control solution containing a know…
Liberty Healthcare Group, Inc.2005—

Also cleared against K030703: 1 other device →

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 12 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
  • 3 of the 14 ancestors have a recall of any class.
  • 1 other device also cites its predicate K030703.

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. 2007, this device’s year, is highlighted.

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 Home Diagnostics TrackEASE Smart System® and TrueTrack Smart System® Blood Glucose Monitors.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K030703

1 other device cites the same predicate.

  • K092645Fdi Glucose Control Levels 1, 2 and 3Fujirebio Diagnostics,Inc. · 2009

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/K070649 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070649: SMS Glucose Control, Model 2120061.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070649

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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