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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 the device name listed in this FDA 510(k) record. The listed applicant is Arlington Scientific, Inc. (Asi). It received FDA 510(k) clearance on 2020-10-21 under 510(k) 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. The listed applicant is Arlington Scientific, Inc. (Asi). The 510(k) number is K201438.

When did ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer receive FDA 510(k) clearance?

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 510(k) number K201438.

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

The FDA 510(k) record lists Arlington Scientific, Inc. (Asi) as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07563309A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid TestRECRUITINGNCT07569913A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid TestNOT_YET_RECRUITINGNCT06927843Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious SyphilisACTIVE_NOT_RECRUITINGNCT07498153Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare SettingCOMPLETED

Other records listing Arlington Scientific, Inc. (Asi) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182391ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionK173376ASI Evolution

Related Devices (Code: GMQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLCK182391ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionArlington Scientific, Inc. (Asi)K173376ASI EvolutionArlington Scientific, Inc. (Asi)

Official Source

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

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