510(k) · Cleared
ClearedSyphilis Health Check
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostics Direct, LLC · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Cleared on Aug 1, 2011 as substantially equivalent to K001552 (Phoenix Biotech Corp., 2000) after a 342-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Aug 1, 2011
- Review
- 342 days
- Class
- Class II
- Product code
- LIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001552 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK001552 Trepchek Treponemal Antibody EiaPhoenix Biotech Corp. · 2000 · Recalled
- This deviceK102400 Syphilis Health CheckDiagnostics Direct, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001552 | Trepchek Treponemal Antibody Eia | Phoenix Biotech Corp. | 2000 | 3 |
| 0 (this device) | K102400 | Syphilis Health Check | Diagnostics Direct, LLC | 2011 | — |
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 LIP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LIP device
- #1 K241534 VITROS Immunodiagnostic Products Syphilis…score 9.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K001552 | Trepchek Treponemal Antibody EiaSummary page 1…21 CFR 866.3830 Classification Class 11(Special Controls) Product Codes LIP Panel: Immunology and Microbiology (83) Predicate Device: K001 552 - Phoenix Bio-Tech - TREPCHEK TREPONEMAL ANTIBODY EIA Device Description SYPHILIS HEALTH CHECK is a rapid qualitative screening… | 2000 |
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K001552.
How does its category compare?
All LIP devicesLIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LIP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIP
170in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LIP
112in 2025
MAUDE reports naming product code LIP, 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 | 1 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 4 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 3 | 170 | 0 | 1 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 46 |
| 2021 | 1 | — | 2 | 54 |
| 2022 | 0 | — | 2 | 44 |
| 2023 | 0 | — | 0 | 66 |
| 2024 | 2 | — | 0 | 73 |
| 2025 | 0 | — | 0 | 112 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
Syphilis Health Check is a qualitative rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human whole blood, serum or plasma. This product can be used as an initial screening test or in conjunction with a non-treponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. This test is not intended for use in screening blood or plasma donors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102400: Syphilis Health Check.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102400
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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