Cleared Traditional

K182391 - ASI Automated ASI RPR Test for Syphilis on the ASI Evolution

K182391 is an FDA 510(k) clearance for ASI Automated ASI RPR Test for Syphilis..., manufactured by Arlington Scientific, Inc. (Asi). The device is a Class 2 Microbiology device with product code GMQ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K182391 · Arlington Scientific, Inc. (Asi) · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
87d
Days
Class 2
Risk

K182391 is an FDA 510(k) clearance for the ASI Automated ASI RPR Test for Syphilis on the ASI Evolution. 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 November 30, 2018 after a review of 87 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arlington Scientific, Inc. (Asi) devices

FDA 510(k) Submission Details - K182391

510(k) Number K182391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2018
Decision Date November 30, 2018
Days to Decision 87 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 102d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMQ Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K182391.
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
K250249 · Gold Standard Diagnostics, LLC · Oct 2025
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
K201438 · Arlington Scientific, Inc. (Asi) · Oct 2020
ASI Evolution
K173376 · Arlington Scientific, Inc. (Asi) · Jun 2018
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
K150358 · Gold Standard Diagnostics · Nov 2015
SYNTHETIC VDRL ANTIGEN
K993633 · Centers For Disease Control and Prevention · Feb 2000
AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI
K992124 · Avanti Polar Lipids, Inc. · Sep 1999