Cleared Traditional

K103363 - ZEUS ELISA HSV GC-I IGG TEST SYSTEM

K103363 is an FDA 510(k) clearance for ZEUS ELISA HSV GC-I IGG TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code MXJ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K103363 · Zeus Scientific, Inc. · Microbiology device
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Apr 2011
Decision
160d
Days
Class 2
Risk

K103363 is an FDA 510(k) clearance for the ZEUS ELISA HSV GC-I IGG TEST SYSTEM. Classified as Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (product code MXJ), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 26, 2011 after a review of 160 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 Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K103363

510(k) Number K103363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2010
Decision Date April 26, 2011
Days to Decision 160 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 102d · This submission: 160d
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 9
Devices cleared under the same product code (MXJ) and FDA review panel - the closest regulatory comparables to K103363.
ADVIA Centaur Herpes-1 IgG
K181333 · Biokit, S.A. · Aug 2018
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
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K090409 · Bio-Rad Laboratories · May 2009
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
K081685 · DiaSorin, Inc. · Nov 2008
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
K072178 · Zeus Scientific, Inc. · May 2008