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FDA 510(k)

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

K-Number: K201438 · 2020-10-21

ApplicantArlington Scientific, Inc. (Asi)
Decision Date2020-10-21
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer is a medical device manufactured by Arlington Scientific, Inc. (Asi). It received FDA 510(k) clearance on 2020-10-21 under approval number K201438. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer?

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer is a medical device that received FDA 510(k) clearance on 2020-10-21. It is manufactured by Arlington Scientific, Inc. (Asi). The 510(k) number is K201438.

When was ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer approved by the FDA?

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer received FDA 510(k) clearance on 2020-10-21, under approval number K201438.

What company makes ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer?

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer is manufactured by Arlington Scientific, Inc. (Asi).

What is the FDA product code for ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer?

The FDA product code for ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer is GMQ.

Related Clinical Trials

NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED NCT06645106 Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department RECRUITING NCT07569913 A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test NOT_YET_RECRUITING NCT07563309 A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test RECRUITING NCT06927843 Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious Syphilis ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41276747 Regulatory Challenges and Opportunities: A Review of U.S. Food and Drug Administration-Approved Artificial Intelligence and Machine Learning-Enabled Cardiovascular Devices. Therapeutic innovation & regulatory science (2026)

Other Devices by Arlington Scientific, Inc. (Asi)

K182391ASI Automated ASI RPR Test for Syphilis on the ASI Evolution K173376ASI Evolution

Related Devices (Code: GMQ)

K182391ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionArlington Scientific, Inc. (Asi) K173376ASI EvolutionArlington Scientific, Inc. (Asi) K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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