Cleared Traditional

K946353 - EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY

K946353 is an FDA 510(k) clearance for EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECO..., manufactured by Mrl Diagnostics. The device is a Class 1 Microbiology device with product code LLM cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K946353 · Mrl Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
203d
Days
Class 1
Risk

K946353 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Mrl Diagnostics (Cypress, US). The FDA issued a Cleared decision on July 21, 1995 after a review of 203 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 Mrl Diagnostics devices

FDA 510(k) Submission Details - K946353

510(k) Number K946353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1994
Decision Date July 21, 1995
Days to Decision 203 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
101d slower than avg
Panel avg: 102d · This submission: 203d
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 20
Devices cleared under the same product code (LLM) and FDA review panel - the closest regulatory comparables to K946353.
IMMUNOWELL EBNA IGG TEST
K973941 · Genbio · Aug 1998
EBNA-1 IGM ELISA TEST SYSTEM
K980598 · Clark Laboratories, Inc. · May 1998
EBNA IGG ELISA TEST
K935730 · Gull Laboratories, Inc. · Sep 1995
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
K946158 · Incstar Corp. · Jun 1995
EBNA IGG ELISA TEST SYSTEM
K932742 · Zeus Scientific, Inc. · May 1995
ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA
K930002 · Ortho Diagnostic Systems, Inc. · Jul 1993