Cleared Traditional

K181334 - ADVIA Centaur Herpes-2 IgG (FDA 510(k) Clearance)

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

K181334 · Biokit, S.A. · Microbiology device
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Aug 2018
Decision
94d
Days
Class 2
Risk

K181334 is an FDA 510(k) clearance for the ADVIA Centaur Herpes-2 IgG. Classified as Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (product code MYF), Class II - Special Controls.

Submitted by Biokit, S.A. (Lliça D'Amunt, ES). The FDA issued a Cleared decision on August 23, 2018 after a review of 94 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 Biokit, S.A. devices

Submission Details

510(k) Number K181334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2018
Decision Date August 23, 2018
Days to Decision 94 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
8d faster than avg
Panel avg: 102d · This submission: 94d
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.