510(k) · Cleared
ClearedTech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simplicity Diagnostics, Inc. · MJX Kit, Serological, Positive Control
Cleared on Mar 10, 1997 after a 59-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- Mar 10, 1997
- Review
- 59 days
- Class
- Class I
- Product code
- MJX
- Recalls
- None
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MJX? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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.
How does its category compare?
All MJX devicesMJX Kit, Serological, Positive Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJX
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · MJX
Too few MJX 510(k)s in any year since 2007 to give a median.
Recalls per year · MJX
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJX
No MAUDE report names MJX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K970100 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970100: Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970100
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026