Home / 510(k) Clearances / K201438

510(k) K201438

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer by Arlington Scientific, Inc. (Asi) — Product Code GMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2020
Date Received
June 1, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Nontreponemal, All
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

Other clearances by Arlington Scientific, Inc. (Asi)

  • K182391 — ASI Automated ASI RPR Test for Syphilis on the ASI Evolution (November 30, 2018)
  • K173376 — ASI Evolution (June 14, 2018)

Other clearances for product code GMQ

  • K250249 — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test (October 10, 2025)
  • K182391 — ASI Automated ASI RPR Test for Syphilis on the ASI Evolution (November 30, 2018)
  • K173376 — ASI Evolution (June 14, 2018)
  • K150358 — Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test Syste (November 12, 2015)
  • K000687 — THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST (June 12, 2000)
  • K993633 — SYNTHETIC VDRL ANTIGEN (February 23, 2000)
  • K992124 — AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI (September 20, 1999)
  • K954994 — TRUST (October 18, 1996)
  • K955136 — RPR CARD TEST KIT (July 29, 1996)
  • K952802 — VISUWELL REAGIN II (May 23, 1996)