# K201438: ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Arlington Scientific, Inc. (Asi)
- Decided: Oct 21, 2020 after 142 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
Longest line of descent: 2 generations back to K851504 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173376: ASI Evolution, Arlington Scientific, Inc. (Asi) (2018) Summary page 4.
- K182391: ASI Automated ASI RPR Test for Syphilis on the ASI Evolution, Arlington Scientific, Inc. (Asi) (2018) Summary page 4.

## Cited in the summary but kept off the family tree
- K170114: MagVita TMS Therapy - w/MagPro R20, Tonica Elektronik A/S (2017). The summary prints BK170114, a CBER number, which our reading took as K170114, FDA’s number for MagVita TMS Therapy - w/MagPro R20 (Tonica Elektronik A/S). Its FDA name has none of the distinctive words the summary uses for the device it names, “ASI RPR Card Test for Syphilis on the ASI Evolution”. Kept off the family tree. Summary page 4.

## Indications for use
The ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Analyzer, is a qualitative and semiquantitative flocculation test for the detection of nontreponemal antibodies in human serum and plasma to aid in the diagnosis of syphilis. All reactive RPR test samples should be further tested with a treponemal test to determine serological evidence of syphilis infection. The test is intended to be used for in vitro diagnostic testing. The ASI Automated RPR Test for Syphilis is for professional use only.

Source page: https://510kreport.com/device/K201438
Methodology: https://510kreport.com/methodology