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510(k) K131334

HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST by Gold Standard Diagnostics — Product Code MXJ

K131334 is an FDA 510(k) premarket notification submitted by Gold Standard Diagnostics for the device "HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST". The FDA issued a decision of Substantially Equivalent on February 28, 2014. The device falls under product code MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1), a Class II device regulated under 21 CFR 866.3305. Gold Standard Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2014
Date Received
May 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Gold Standard Diagnostics

  • K250249 — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test (October 10, 2025)
  • 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)
  • K203295 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (March 22, 2021)
  • K203292 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (March 22, 2021)
  • K200025 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (April 6, 2020)
  • K200023 — Gold Standard Diagnostics Borrelia burgdorferi IgM 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)
  • K131330 — GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT (January 28, 2014)

Other clearances for product code MXJ

  • K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Control (September 20, 2023)
  • K220923 — Elecsys HSV-1 IgG (08948844160) (October 12, 2022)
  • K181333 — ADVIA Centaur Herpes-1 IgG (August 23, 2018)
  • K162276 — SeraQuest Herpes Type 1 Specific IgG (October 1, 2016)
  • K143236 — Theranos Herpes Simplex Virus-1 IgG Assay (July 2, 2015)
  • K120625 — ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV (July 25, 2012)
  • K120959 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT (June 22, 2012)
  • K103363 — ZEUS ELISA HSV GC-I IGG TEST SYSTEM (April 26, 2011)
  • K090409 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYS (May 8, 2009)
  • K081685 — LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG (November 18, 2008)

FDA data resources