Cleared Traditional

K233605 - ADVIA Centaur EBV-EBNA IgG (FDA 510(k) Clearance)

Class I Microbiology device.

K233605 · Biokit, S.A. · Microbiology device
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Aug 2024
Decision
272d
Days
Class 1
Risk

K233605 is an FDA 510(k) clearance for the ADVIA Centaur EBV-EBNA IgG. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Biokit, S.A. (Lliçà D’Amunt, Barcelona, ES). The FDA issued a Cleared decision on August 7, 2024 after a review of 272 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - 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 K233605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2023
Decision Date August 07, 2024
Days to Decision 272 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
170d slower than avg
Panel avg: 102d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLM Test, Antigen, Nuclear, Epstein-barr Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.