510(k) · Cleared
ClearedSMS Multi Glucose Control, Model 2120049
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Specialties Supply Co., Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Apr 18, 2007 as substantially equivalent to K011479 (Inverness Medical Innovations, Inc., 2001) and 2 other predicates after a 56-day review. Its family tree reaches back 7 generations to 1995. 5 later devices descend from it.
- Decided
- Apr 18, 2007
- Review
- 56 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K945887 (1995). 16 ancestors in all, the oldest K850368 (1985). 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 6 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 5 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 4 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 3 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 2 generations backK052980 Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
- 1 generation backK060706 Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
- This deviceK070506 SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007
- Descendant · cites it directly · 2 of its ownK081403 Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK123851 Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK082395 Glucose Meter-Check Control Solution for Bayer Ascensia Blood…Bionostics, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK152493 POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK123966 Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008 · cites it directly2descendants
- K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013 · 2 generations on1descendant
- K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc. · 2008 · cites it directly1descendant
- K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2016 · 3 generations on0descendants
- K123966Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −6 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −5 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −4 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −3 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −2 | K052980 | Liberty Glucose Control, Model 2120031 | Liberty Healthcare Group, Inc. | 2005 | — |
| −1 | K060706 | Liberty Normal Glucose Control Solution | Liberty Healthcare Group, Inc. | 2006 | — |
| 0 (this device) | K070506 | SMS Multi Glucose Control, Model 2120049 | Medical Specialties Supply Co., Inc. | 2007 | — |
| +1 | K081403 | Glucose Meter-Check Control Solution for Roche Accu-Chek | Bionostics, Inc. | 2008 | — |
| +2 | K123851 | Glucose Meter-Check Solution for Roche Accu-Chek | Bionostics, Inc. | 2013 | — |
| +1 | K082395 | Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter… | Bionostics, Inc. | 2008 | — |
| +3 | K152493 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | 2016 | — |
| +2 | K123966 | Glucose Meter-Check Solution for Bayer | Bionostics, Inc. | 2013 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K011479 | One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood…Summary page 1…OneTouch Ultra Control Solution Manufacturer: LifeScan, Inc. 51 0(k) No.: K011479 Name: Ascensia Microfill Control… | 2001 |
| 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 51 0(k) No.: K023657 Page 9 of 34 510(k) Premarket Notification: SMS Multi Glucose Contro… | |
| * | K011738 | Accu-Chek Active SystemSummary page 2…Level Manufacturer: Roche Diagnostics Corporation 510(k) No.: K011738 Name: Liberty Glucose Control Manufacture… | 2001 |
| * | K060706 | Liberty Normal Glucose Control SolutionSummary page 2…iberty Glucose Control Manufacturer: Liberty Healthcare Group, Inc. 510(k) No.: K060706 Device Description: The SMS Multi Glucose Control consists of a viscosity-adju… | 2006 |
What descends from it? (5)
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 12 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K081403 (Bionostics, Inc., 2008) has gone furthest, with 2 descendants of its own.
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. 2007, 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?
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 Contour, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070506: SMS Multi Glucose Control, Model 2120049.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070506
Report an extraction error
Are you the manufacturer?
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