Cleared Traditional

LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG (K081687) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081687 · DiaSorin, Inc. · Microbiology device
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Nov 2008
Decision
146d
Days
Class 2
Risk

K081687 is an FDA 510(k) clearance for the LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG. Classified as Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (product code MYF), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on November 10, 2008 after a review of 146 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 DiaSorin, Inc. devices

Submission Details

510(k) Number K081687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date November 10, 2008
Days to Decision 146 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
44d slower than avg
Panel avg: 102d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
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 - MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

All 9
Devices cleared under the same product code (MYF) and FDA review panel - the closest regulatory comparables to K081687.
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
K243575 · Biokit, S.A. · Feb 2025
Elecsys HSV-2 IgG (08948887160)
K220924 · Roche Diagnostics · Oct 2022
SeraQuest HSV Type 2 Specific IgG
K181514 · Quest International, Inc. · Jun 2019
ADVIA Centaur Herpes-2 IgG
K181334 · Biokit, S.A. · Aug 2018