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510(k) K182391

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

K182391 is an FDA 510(k) premarket notification submitted by Arlington Scientific, Inc. (Asi) for the device "ASI Automated ASI RPR Test for Syphilis on the ASI Evolution". The FDA issued a decision of Substantially Equivalent on November 30, 2018. The device falls under product code GMQ (Antigens, Nontreponemal, All), a Class II device regulated under 21 CFR 866.3820. Arlington Scientific, Inc. (Asi) has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2018
Date Received
September 4, 2018
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)

  • K201438 — ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Ev (October 21, 2020)
  • 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)
  • K201438 — ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Ev (October 21, 2020)
  • 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)

FDA data resources