510(k) · Cleared
ClearedFdi Glucose Control Solution for Freestyle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jan 25, 2011 as substantially equivalent to K102260 (Fujirebio Diagnostics,Inc., 2010) after a 62-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Jan 25, 2011
- Review
- 62 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945887 (1995). 30 ancestors in all, the oldest K850368 (1985). No later device cites it as a predicate yet.
- Root · 9 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 5 generations between
- 3 generations backK060481 Liberty Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
- 2 generations backK083549 Abt Glucose Control SolutionAmerican Biological Technologies, Inc. · 2008
- 1 generation backK102260 Fdi Glucose Control SolutionsFujirebio Diagnostics,Inc. · 2010
- This deviceK103450 Fdi Glucose Control Solution for FreestyleFujirebio Diagnostics,Inc. · 2011
Show all 9 generations
- Root · 9 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 8 generations backK970707 Elect II Blood Glucose Monitoring SystemSelfcare, Inc. · 1997
- 7 generations backK992684 Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- 6 generations backK012014 Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2001
- 5 generations backK020866 Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc. · 2002
- 4 generations backK031260 Freestyle Blood Glucose Monitoring System, Freestyle Tracker…Abbott Diabetes Care, Inc. · 2003
- 3 generations backK060481 Liberty Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
- 2 generations backK083549 Abt Glucose Control SolutionAmerican Biological Technologies, Inc. · 2008
- 1 generation backK102260 Fdi Glucose Control SolutionsFujirebio Diagnostics,Inc. · 2010
- This deviceK103450 Fdi Glucose Control Solution for FreestyleFujirebio Diagnostics,Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −8 | K970707 | Elect II Blood Glucose Monitoring System | Selfcare, Inc. | 1997 | — |
| −7 | K992684 | Freestyle Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2000 | 2 |
| −6 | K012014 | Modification to Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2001 | — |
| −5 | K020866 | Freestyle Tracker Diabetes Management System | Abbott Diabetes Care, Inc. | 2002 | — |
| −4 | K031260 | Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes… | Abbott Diabetes Care, Inc. | 2003 | — |
| −3 | K060481 | Liberty Glucose Control Solution | Liberty Healthcare Group, Inc. | 2006 | — |
| −2 | K083549 | Abt Glucose Control Solution | American Biological Technologies, Inc. | 2008 | — |
| −1 | K102260 | Fdi Glucose Control Solutions | Fujirebio Diagnostics,Inc. | 2010 | — |
| 0 (this device) | K103450 | Fdi Glucose Control Solution for Freestyle | Fujirebio Diagnostics,Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102260 | Fdi Glucose Control SolutionsSummary page 2…lucose Control Solution FOI Glucose Control Solution ________________________________forFreeStyle 510(k), Date K102260, 09/24/20 10 _____________ Number of 1… | 2010 |
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 16 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 30 ancestors have a recall of any class.
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. 2011, 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 FreeStyle Blood Glucose Monitor
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103450 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103450: Fdi Glucose Control Solution for Freestyle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103450
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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