Cleared Traditional

SERAQUEST EBV EA-D IGG TEST (K091260) - FDA 510(k) Clearance

Class I Microbiology device.

K091260 · Quest Intl., Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
40d
Days
Class 1
Risk

K091260 is an FDA 510(k) clearance for the SERAQUEST EBV EA-D IGG TEST. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Quest Intl., Inc. (Mami, US). The FDA issued a Cleared decision on June 8, 2009 after a review of 40 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quest Intl., Inc. devices

Submission Details

510(k) Number K091260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2009
Decision Date June 08, 2009
Days to Decision 40 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
62d faster than avg
Panel avg: 102d · This submission: 40d
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.