Cleared Traditional

K143236 - Theranos Herpes Simplex Virus-1 IgG Assay

K143236 is an FDA 510(k) clearance for Theranos Herpes Simplex Virus-1 IgG Assay, manufactured by Theranos, Inc.. The device is a Class 2 Microbiology device with product code MXJ cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K143236 · Theranos, Inc. · Microbiology device
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Jul 2015
Decision
232d
Days
Class 2
Risk

K143236 is an FDA 510(k) clearance for the Theranos Herpes Simplex Virus-1 IgG Assay. Classified as Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (product code MXJ), Class II - Special Controls.

Submitted by Theranos, Inc. (Palo Alto, US). The FDA issued a Cleared decision on July 2, 2015 after a review of 232 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Theranos, Inc. devices

FDA 510(k) Submission Details - K143236

510(k) Number K143236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2014
Decision Date July 02, 2015
Days to Decision 232 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 102d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXJ Device Classification - Class 2, Special Controls

Product Code MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

All 13
Devices cleared under the same product code (MXJ) and FDA review panel - the closest regulatory comparables to K143236.
Elecsys HSV-1 IgG (08948844160)
K220923 · Roche Diagnostics · Oct 2022
ADVIA Centaur Herpes-1 IgG
K181333 · Biokit, S.A. · Aug 2018
SeraQuest Herpes Type 1 Specific IgG
K162276 · Quest International, Inc. · Oct 2016
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
K131334 · Gold Standard Diagnostics · Feb 2014
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
K120625 · Roche Diagnostics · Jul 2012
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
K120959 · Bio-Rad Laboratories · Jun 2012