Cleared Traditional

K062543 - HERPESELECT 1 AND 2 PLEXUS IGG

K062543 is the FDA 510(k) clearance for HERPESELECT 1 AND 2 PLEXUS IGG by Focus Diagnostics, Inc.. It is a Class 2 Microbiology device (product code MXJ) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K062543 · Focus Diagnostics, Inc. · Microbiology device
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Feb 2007
Decision
155d
Days
Class 2
Risk

K062543 is an FDA 510(k) clearance for the HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G. Classified as Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (product code MXJ), Class II - Special Controls.

Submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on February 1, 2007 after a review of 155 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 Focus Diagnostics, Inc. devices

Submission Details

510(k) Number K062543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2006
Decision Date February 01, 2007
Days to Decision 155 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
53d slower than avg
Panel avg: 102d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K062543.
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