Cleared Traditional

K073382 - PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS

K073382 is the FDA 510(k) clearance for PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS by Focus Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LSE) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K073382 · Focus Diagnostics, Inc. · Microbiology device
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Jul 2008
Decision
238d
Days
Class 1
Risk

K073382 is an FDA 510(k) clearance for the PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on July 28, 2008 after a review of 238 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

Submission Details

510(k) Number K073382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2007
Decision Date July 28, 2008
Days to Decision 238 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
136d slower than avg
Panel avg: 102d · This submission: 238d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LSE Epstein-barr Virus, Other
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 - LSE Epstein-barr Virus, Other

All 24
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