Cleared Traditional

K991975 - SERAQUEST EB NA IGG

K991975 is the FDA 510(k) clearance for SERAQUEST EB NA IGG by Quest Intl., Inc.. It is a Class 1 Microbiology device (product code LSE) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K991975 · Quest Intl., Inc. · Microbiology device
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Nov 1999
Decision
144d
Days
Class 1
Risk

K991975 is an FDA 510(k) clearance for the SERAQUEST EB NA 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 November 2, 1999 after a review of 144 days - within the typical 510(k) review window.

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 K991975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1999
Decision Date November 02, 1999
Days to Decision 144 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
42d slower than avg
Panel avg: 102d · This submission: 144d
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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