Cleared Traditional

K993754 - HSV-1 ELISA IGG, MODEL EL0910G

K993754 is an FDA 510(k) clearance for HSV-1 ELISA IGG, manufactured by Mrl Diagnostics. The device is a Class 2 Microbiology device with product code MXJ cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K993754 · Mrl Diagnostics · Microbiology device
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Feb 2000
Decision
96d
Days
Class 2
Risk

K993754 is an FDA 510(k) clearance for the HSV-1 ELISA IGG, MODEL EL0910G. Classified as Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (product code MXJ), Class II - Special Controls.

Submitted by Mrl Diagnostics (Cypress, US). The FDA issued a Cleared decision on February 9, 2000 after a review of 96 days - within the typical 510(k) review window.

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 Mrl Diagnostics devices

FDA 510(k) Submission Details - K993754

510(k) Number K993754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1999
Decision Date February 09, 2000
Days to Decision 96 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 102d · This submission: 96d
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 10
Devices cleared under the same product code (MXJ) and FDA review panel - the closest regulatory comparables to K993754.
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
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
K984343 · Meridian Diagnostics, Inc. · Jun 1999