Cleared Traditional

SERAQUEST EB VCA IGG (K990410) - FDA 510(k) Clearance

Class I Microbiology device.

K990410 · Quest Intl., Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
261d
Days
Class 1
Risk

K990410 is an FDA 510(k) clearance for the SERAQUEST EB VCA IGG. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on October 28, 1999 after a review of 261 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 Quest Intl., Inc. devices

Submission Details

510(k) Number K990410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1999
Decision Date October 28, 1999
Days to Decision 261 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
159d slower than avg
Panel avg: 102d · This submission: 261d
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.