# K851504: VDRL Carbon Antigen Test S900500, S900250 & S90010

- Pathway: 510(k) (Traditional)
- Applicant: Ncs Diagnostics, Inc.
- Decided: Aug 19, 1985 after 126 days
- Product code: GMP (Antisera, Control For Nontreponemal Tests)
- Device class: 2
- Regulation: 21 CFR 866.3820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K111356: Asimanager - at (2011), 2 descendants of its own
- K173376: ASI Evolution (2018), 1 descendant of its own
- K150358: Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (2015), 1 descendant of its own
- K250249: Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (2025), 0 descendants of its own
- K201438: ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K851504
Methodology: https://510kreport.com/methodology