# K111356: Asimanager - at

- Pathway: 510(k) (Traditional)
- Applicant: Arlington Scientific, Inc.
- Decided: Nov 9, 2011 after 177 days
- Product code: JQT (Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica)
- Device class: 1
- Regulation: 21 CFR 862.2400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851504 (1985). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851504: VDRL Carbon Antigen Test S900500, S900250 & S90010, Ncs Diagnostics, Inc. (1985) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The ASiManager-AT is intended to be used as an integrated digital particle analyzer to objectively interpret the ASI RPR Card Test for Syphilis. The ASiManager-AT is designed to provide standardized test interpretation, an initial predictive titer analysis, and provides for storage, retrieval, and transmittal of the test results. It is intended to be acquired, possessed and used only by health care professionals. For in vitro Diagnostic Use Only, not intended for screening blood and tissue donors.

Source page: https://510kreport.com/device/K111356
Methodology: https://510kreport.com/methodology