De Novo · Granted
GrantedFirst To Know Syphilis Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nowdiagnostics · SBZ Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
Granted on Aug 16, 2024 as a new device type through De Novo after a 233-day review.
- Decided
- Aug 16, 2024
- Review
- 233 days
- Class
- Class II
- Product code
- SBZ
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 SBZ? 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
Does it have a predicate?
De Novo decisions do not claim a predicate 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.
How does its category compare?
All SBZ devicesSBZ Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SBZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SBZ
Too few SBZ 510(k)s in any year since 2007 to give a median.
Recalls per year · SBZ
No recall names SBZ since 2007.
Adverse event reports per year · SBZ
1in 2025
MAUDE reports naming product code SBZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 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 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The First To Know Syphilis Test is a qualitative rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human whole blood (capillary). This test is intended for over the counter (OTC) consumer use in individuals suspected of syphilis. Positive test results with the First To Know Syphilis Test alone are not sufficient to diagnose syphilis infection and must be followed by additional laboratory testing…
Read the full statement (153 words)
The First To Know Syphilis Test is a qualitative rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human whole blood (capillary). This test is intended for over the counter (OTC) consumer use in individuals suspected of syphilis. Positive test results with the First To Know Syphilis Test alone are not sufficient to diagnose syphilis infection and must be followed by additional laboratory testing through a health care provider to confirm a diagnosis of syphilis.
This test is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop or change any treatments without a healthcare provider.
Results of testing with the First To Know Syphilis Test will likely be positive for individuals previously diagnosed with syphilis, even if they were successfully treated. The First To Know Syphilis Test cannot determine whether there has been re-infection with syphilis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230090 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230090: First To Know Syphilis Test.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230090
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)
- Page last updated Nov 3, 2026