510(k) · Cleared
Recalled · 2005Trepchek Treponemal Antibody Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phoenix Biotech Corp. · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Cleared on Oct 19, 2000 after a 154-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 19, 2000
- Review
- 154 days
- Class
- Class II
- Product code
- LIP
- Recalls
- 3
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK001552 Trepchek Treponemal Antibody EiaPhoenix Biotech Corp. · 2000
- Descendant · cites it directly · 1 of its ownK063866 Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte…Bio-Rad Laboratories · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK120439 Bioplex 2200 Ebv Igg and Syphilis IggBio-Rad Laboratories, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK102400 Syphilis Health CheckDiagnostics Direct, LLC · 2011
Most influential descendants
Showing 3 of 3 · See all- K063866Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories · 2007 · cites it directly1descendant
- K120439Bioplex 2200 Ebv Igg and Syphilis IggBio-Rad Laboratories, Inc. · 2012 · 2 generations on0descendants
- K102400Syphilis Health CheckDiagnostics Direct, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001552 | Trepchek Treponemal Antibody Eia | Phoenix Biotech Corp. | 2000 | — |
| +1 | K063866 | Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories | 2007 | 3 |
| +2 | K120439 | Bioplex 2200 Ebv Igg and Syphilis Igg | Bio-Rad Laboratories, Inc. | 2012 | — |
| +1 | K102400 | Syphilis Health Check | Diagnostics Direct, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2005 | Not classified | Z-0784-05 | Other | Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter. |
| Dec 9, 2003 | Not classified | Z-0513-04 | Other | The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results. |
| Sep 11, 2003 | Not classified | Z-0325-05 | Other | Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K063866 (Bio-Rad Laboratories, 2007) has gone furthest, with 1 descendant of its own.
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.
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 | — |
https://510kreport.com/device/K001552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001552: Trepchek Treponemal Antibody Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001552
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026