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510(k) K250249

Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System by Gold Standard Diagnostics, LLC — Product Code GMQ

K250249 is an FDA 510(k) premarket notification submitted by Gold Standard Diagnostics, LLC for the device "Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System". The FDA issued a decision of Substantially Equivalent on October 10, 2025. The device falls under product code GMQ (Antigens, Nontreponemal, All), a Class II device regulated under 21 CFR 866.3820. Gold Standard Diagnostics, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2025
Date Received
January 27, 2025
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 Gold Standard Diagnostics, LLC

  • K203292 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (March 22, 2021)
  • K203295 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (March 22, 2021)
  • K203289 — Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit (March 22, 2021)
  • K203296 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (March 22, 2021)
  • K200023 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (April 6, 2020)
  • K200025 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (April 6, 2020)
  • K180264 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (May 2, 2018)
  • K150358 — Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test Syste (November 12, 2015)
  • K131334 — HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST (February 28, 2014)
  • K131330 — GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT (January 28, 2014)

Other clearances for product code GMQ

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

FDA data resources