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510(k) K143236

Theranos Herpes Simplex Virus-1 IgG Assay by Theranos, Inc. — Product Code MXJ

K143236 is an FDA 510(k) premarket notification submitted by Theranos, Inc. for the device "Theranos Herpes Simplex Virus-1 IgG Assay". The FDA issued a decision of Substantially Equivalent on July 2, 2015. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2015
Date Received
November 12, 2014
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

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  • 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