Cleared Traditional

K233605 - ADVIA Centaur EBV-EBNA IgG

K233605 is an FDA 510(k) clearance for ADVIA Centaur EBV-EBNA IgG, manufactured by Biokit, S.A.. The device is a Class 1 Microbiology device with product code LLM cleared through the Traditional 510(k) pathway after a 272-day FDA review.

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

FDA 510(k) Submission Details - K233605

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.

LLM Device Classification - Class 1, General Controls

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.

Regulatory Peers - LLM Test, Antigen, Nuclear, Epstein-barr Virus

All 21
Devices cleared under the same product code (LLM) and FDA review panel - the closest regulatory comparables to K233605.
DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
K040120 · DiaSorin, Inc. · Apr 2005
THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
K984133 · Zeus Scientific, Inc. · Jan 1999
IMMUNOWELL EBNA IGG TEST
K973941 · Genbio · Aug 1998
EBNA-1 IGM ELISA TEST SYSTEM
K980598 · Clark Laboratories, Inc. · May 1998
EBNA IGG EIA TEST SYSTEM
K951549 · Immunoprobe, Inc. · Apr 1996
EBNA ENZYME IMMUNOASSAY KIT
K951822 · Granbio, Inc. · Feb 1996