Cleared Traditional

K073381 - PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M

K073381 is an FDA 510(k) clearance for PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, manufactured by Focus Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LJN cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K073381 · Focus Diagnostics, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Aug 2008
Decision
245d
Days
Class 1
Risk

K073381 is an FDA 510(k) clearance for the PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on August 4, 2008 after a review of 245 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 Focus Diagnostics, Inc. devices

FDA 510(k) Submission Details - K073381

510(k) Number K073381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2007
Decision Date August 04, 2008
Days to Decision 245 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
143d slower than avg
Panel avg: 102d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

LJN Device Classification - Class 1, General Controls

Product Code LJN Antibody Igm, If, 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 - LJN Antibody Igm, If, Epstein-barr Virus

All 16
Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K073381.
BIOPLEX 2200 EBV IGM KIT
K123021 · Bio-Rad Laboratories · Nov 2012
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092 · Zeus Scientific, Inc. · Apr 2005
MODIFICATION TO SERAQUEST VCA IGM
K033780 · Quest Intl., Inc. · Jan 2004
SERAQUEST EB VAC IGM
K990977 · Quest Intl., Inc. · Oct 1999
COPALIS EBV-M ANTIBODY ASSAY
K991459 · DiaSorin, Inc. · May 1999
IMMUNOWELL VCA IGM TEST
K973939 · Genbio · Aug 1998