Cleared Traditional

K181333 - ADVIA Centaur Herpes-1 IgG

K181333 is the FDA 510(k) clearance for ADVIA Centaur Herpes-1 IgG by Biokit, S.A.. It is a Class 2 Microbiology device (product code MXJ) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K181333 · Biokit, S.A. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
94d
Days
Class 2
Risk

K181333 is an FDA 510(k) clearance for the ADVIA Centaur Herpes-1 IgG. Classified as Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (product code MXJ), 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 K181333 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
Combination Product No
PCCP Authorized No
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 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 K181333.
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
K213987 · Biokit, S.A. · Sep 2023
Elecsys HSV-1 IgG (08948844160)
K220923 · Roche Diagnostics · Oct 2022
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
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
K103363 · Zeus Scientific, Inc. · Apr 2011
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K090409 · Bio-Rad Laboratories · May 2009