510(k) Report

510(k) · Cleared

Cleared

ASI Evolution

K173376510(k) TraditionalCleared Jun 14, 2018227-day reviewClass II21 CFR 866.3820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arlington Scientific, Inc. (Asi) · GMQ Antigens, Nontreponemal, All

Cleared on Jun 14, 2018 as substantially equivalent to K851504 (Ncs Diagnostics, Inc., 1985) after a 227-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided
Jun 14, 2018
Review
227 days
Class
Class II
Product code
GMQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K851504 (1985). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2020: 1 descendant clearedK851504 · VDRL Carbon Antigen Test S900500, S900250 & S90010 · Ncs Diagnostics, Inc. · 19851990200020102020
Descendants, by generation 1 generation forward: 1 descendant K851504 · VDRL Carbon Antigen Test S900500, S900250 & S90010 · Ncs Diagnostics, Inc. · 19850
  1. Root · 1 generation backK851504 VDRL Carbon Antigen Test S900500, S900250 & S90010Ncs Diagnostics, Inc. · 1985
  2. This deviceK173376 ASI EvolutionArlington Scientific, Inc. (Asi) · 2018
  3. Descendant · cites it directly · 0 of its ownK201438 ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use…Arlington Scientific, Inc. (Asi) · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution…Arlington Scientific, Inc. (Asi) · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K851504VDRL Carbon Antigen Test S900500, S900250 & S90010Ncs Diagnostics, Inc.1985—
0 (this device)K173376ASI EvolutionArlington Scientific, Inc. (Asi)2018—
+1K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI…Arlington Scientific, Inc. (Asi)2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K173376, 1985–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GMQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GMQ device

  1. #1 K250249 Gold Standard Diagnostics (GSD) AIX1000 Rapid…score 10.8 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K851504VDRL Carbon Antigen Test S900500, S900250 & S90010
Summary page 4
…ion: Class II Product Code: GMQ Panel: Microbiology 5.3 Predicate Device(s) – ASI RPR Card Test for Syphilis on the ASiManager-AT (K851504) Device Similarities and Differences Item ASI Evolut…
Ncs Diagnostics, Inc.1985—

Also cleared against K851504: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution…Arlington Scientific, Inc. (Asi)20200

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?

  • Its one ancestor has no recall.
  • Of its descendants, K201438 (Arlington Scientific, Inc. (Asi), 2020) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K851504.

How does its category compare?

All GMQ devices

GMQ Antigens, Nontreponemal, All: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · GMQ

1in 2025

2015: 12018: 22020: 12025: 1
2007high 2 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GMQ

Too few GMQ 510(k)s in any year since 2007 to give a median.

Recalls per year · GMQ

No recall names GMQ since 2007.

Adverse event reports per year · GMQ

2in 2024

2007: 32008: 22011: 12017: 12021: 32022: 142023: 62024: 2
2007high 14 (2022) · low 0 (2009)2025

MAUDE reports naming product code GMQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—02
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20151—00
20160—00
20170—01
20182—00
20190—00
20201—00
20210—03
20220—014
20230—06
20240—02
20251—00
20260—0—

What is it indicated for?

The ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer, is a qualitative nontreponemal flocculation test for the detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis. All reactive RPR test samples should be further tested with a treponemal test. The ASI Automated RPR Test for Syphilis for use on the ASI Evolution produces only a…

Read the full statement (224 words)

The ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer, is a qualitative nontreponemal flocculation test for the detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis. All reactive RPR test samples should be further tested with a treponemal test. The ASI Automated RPR Test for Syphilis for use on the ASI Evolution produces only a reactive or non-reactive result and does not report RPR titers for reactive samples.

The ASI Automated RPR Test for Syphilis is for professional use only. The test is intended to be used for in vitro diagnostic testing.

The ASI Evolution is intended to be used as a fully automated analyzer to objectively interpret the results of the ASI automated RPR test for syphilis. The ASI Evolution is designed to provide standardized test interpretation and to provide for storage, retrieval, and transmittal of the test results. It is intended to be acquired, possessed and used only by health care professionals. The ASI Evolution analyzer, in conjunction with the ASI Automated RPR Test is intended to be used for in vitro diagnostic testing. The ASI Automated RPR Test for Syphilis for use on the ASI Evolution produces only a reactive or non-reactive result and does not report RPR titers for reactive samples.

Indications for use as stated in the FDA summary.

Also cleared against K851504

1 other device cites the same predicate.

  • K111356Asimanager - atArlington Scientific, Inc. · 2011

More from Arlington Scientific, Inc. (Asi)

3 FDA decisions under this applicant name. See the company

  • K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis…Arlington Scientific, Inc. (Asi) · 2020
  • K182391ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionArlington Scientific, Inc. (Asi) · 2018

Recent decisions in GMQ

The GMQ category page

  • K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLC · 2025
  • K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis…Arlington Scientific, Inc. (Asi) · 2020
  • K182391ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionArlington Scientific, Inc. (Asi) · 2018
  • K150358Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics · 2015
  • K000687The Daya Syphilis Test/the Trust Antigen TestBeacon Biologicals, Inc. · 2000

https://510kreport.com/device/K173376 · printed Nov 5, 2026

Cite this page

510(k) Report. “K173376: ASI Evolution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173376

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026