510(k) · Cleared
ClearedVDRL Carbon Antigen Test S900500, S900250 & S90010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ncs Diagnostics, Inc. · GMP Antisera, Control For Nontreponemal Tests
Cleared on Aug 19, 1985 after a 126-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 19, 1985
- Review
- 126 days
- Class
- Class II
- Product code
- GMP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK851504 VDRL Carbon Antigen Test S900500, S900250 & S90010Ncs Diagnostics, Inc. · 1985
- Descendant · cites it directly · 2 of its ownK111356 Asimanager - atArlington Scientific, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK173376 ASI EvolutionArlington Scientific, Inc. (Asi) · 2018
- Descendant · 2 generations on · 1 of its ownK150358 Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR)…Gold Standard Diagnostics · 2015
- Descendant · 3 generations on · 0 of its ownK250249 Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR)…Gold Standard Diagnostics, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK201438 ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use…Arlington Scientific, Inc. (Asi) · 2020
Most influential descendants
Showing 5 of 5 · See all- K111356Asimanager - atArlington Scientific, Inc. · 2011 · cites it directly2descendants
- K173376ASI EvolutionArlington Scientific, Inc. (Asi) · 2018 · cites it directly1descendant
- K150358Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics · 2015 · 2 generations on1descendant
- K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLC · 2025 · 3 generations on0descendants
- K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution…Arlington Scientific, Inc. (Asi) · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K851504 | VDRL Carbon Antigen Test S900500, S900250 & S90010 | Ncs Diagnostics, Inc. | 1985 | — |
| +1 | K111356 | Asimanager - at | Arlington Scientific, Inc. | 2011 | — |
| +1 | K173376 | ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018 | — |
| +2 | K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test… | Gold Standard Diagnostics | 2015 | — |
| +3 | K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated… | Gold Standard Diagnostics, LLC | 2025 | — |
| +2 | K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI… | Arlington Scientific, Inc. (Asi) | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 GMP? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111356 (Arlington Scientific, Inc., 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GMP devicesGMP Antisera, Control For Nontreponemal Tests: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GMP
FDA has decided no GMP device since 2007.
Median 510(k) review, days · GMP
Too few GMP 510(k)s in any year since 2007 to give a median.
Recalls per year · GMP
No recall names GMP since 2007.
Adverse event reports per year · GMP
No MAUDE report names GMP 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 | 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 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K851504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K851504: VDRL Carbon Antigen Test S900500, S900250 & S90010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K851504
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026