510(k) · Cleared
ClearedContrex Plus Low Control Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex BioTechnology Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Apr 14, 2010 after a 29-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.
- Decided
- Apr 14, 2010
- Review
- 29 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK100747 Contrex Plus Low Control SolutionApex BioTechnology Corp. · 2010
- Descendant · cites it directly · 12 of its ownK102816 Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp. · 2011
- Descendant · 2 generations on · 9 of its ownK113208 Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2012
- Descendant · 3 generations on · 3 of its ownK141036 BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2015
- Descendant · 3 generations on · 3 of its ownK131750 Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2014
- Descendant · 4 generations on · 2 of its ownK170267 BGM009 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K102816Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp. · 2011 · cites it directly12descendants
- K113208Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2012 · 2 generations on9descendants
- K141036BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2015 · 3 generations on3descendants
- K131750Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2014 · 3 generations on3descendants
- K170267BGM009 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2017 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100747 | Contrex Plus Low Control Solution | Apex BioTechnology Corp. | 2010 | — |
| +1 | K102816 | Gal-1C Blood Glucose Monitoring System, Gal-1C Test Strips | Apex BioTechnology Corp. | 2011 | — |
| +2 | K113208 | Gal-1A Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2012 | — |
| +3 | K141036 | BGM009 Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2015 | — |
| +3 | K131750 | Autosure HT Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2014 | — |
| +4 | K170267 | BGM009 Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 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 |
|---|---|---|---|
| * | — | Contrex Plus Level I and Level 2 Control Solutions Named without a submission number |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102816 | Gal-1C Blood Glucose Monitoring System, Gal-1C Test Strips | 2011 | 12 |
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?
- Of its descendants, K102816 (Apex BioTechnology Corp., 2011) has gone furthest, with 12 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. 2010, 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?
The purpose of the control solution test is to validate the performance of the GlucoSure STAR & GlucoTRACK Blood Glucose Monitoring Systems using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100747: Contrex Plus Low 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/K100747
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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