Cleared Traditional

K990410 - SERAQUEST EB VCA IGG

K990410 is an FDA 510(k) clearance for SERAQUEST EB VCA IGG, manufactured by Quest Intl., Inc.. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K990410 · Quest Intl., Inc. · Microbiology device
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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

FDA 510(k) Submission Details - K990410

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 102d · This submission: 261d
Pathway characteristics
Predicate-based equivalence.

LSE Device Classification - Class 1, General Controls

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 47
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K990410.
MODIFICATION TO SERAQUEST EB VCA IGG
K033915 · Quest Intl., Inc. · Jan 2004
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
K992587 · Stellar Bio Systems, Inc. · Dec 1999
SERAQUEST EB NA IGG
K991975 · Quest Intl., Inc. · Nov 1999
ETI-EA-G ASSAY
K992191 · DiaSorin, Inc. · Jul 1999
BIOTEST ANTI-EBV RECOMBINANT
K983839 · Biotest Diagnostics Corp. · Jun 1999
BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG
K983841 · Biotest Diagnostics Corp. · Jun 1999