# K182391: ASI Automated ASI RPR Test for Syphilis on the ASI Evolution

- Pathway: 510(k) (Traditional)
- Applicant: Arlington Scientific, Inc. (Asi)
- Decided: Nov 30, 2018 after 87 days
- Product code: GMQ (Antigens, Nontreponemal, All)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- 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/K182391
Methodology: https://510kreport.com/methodology