Cleared Traditional

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer (K201438) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201438 · Arlington Scientific, Inc. (Asi) · Microbiology device
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Oct 2020
Decision
142d
Days
Class 2
Risk

K201438 is an FDA 510(k) clearance for the ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI.... Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Arlington Scientific, Inc. (Asi) (Springville, US). The FDA issued a Cleared decision on October 21, 2020 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3820 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Arlington Scientific, Inc. (Asi) devices

Submission Details

510(k) Number K201438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2020
Decision Date October 21, 2020
Days to Decision 142 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 102d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GMQ Antigens, Nontreponemal, All
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GMQ Antigens, Nontreponemal, All

All 31
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K201438.
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
K250249 · Gold Standard Diagnostics, LLC · Oct 2025
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
K182391 · Arlington Scientific, Inc. (Asi) · Nov 2018
ASI Evolution
K173376 · Arlington Scientific, Inc. (Asi) · Jun 2018