Cleared Special

K033915 - MODIFICATION TO SERAQUEST EB VCA IGG

K033915 is an FDA 510(k) clearance for MODIFICATION TO SERAQUEST EB VCA IGG, manufactured by Quest Intl., Inc.. The device is a Class 1 Microbiology device with product code LSE cleared through the Special 510(k) pathway after a 29-day FDA review.

K033915 · Quest Intl., Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
29d
Days
Class 1
Risk

K033915 is an FDA 510(k) clearance for the MODIFICATION TO 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 January 16, 2004 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033915

510(k) Number K033915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2003
Decision Date January 16, 2004
Days to Decision 29 days
Submission Type Special
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
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 57
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K033915.
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
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K030863 · Panbio Limited · Jun 2003
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K021793 · Pan Bio Pty. , Ltd. · Sep 2002
IMMUNOWELL EA (D) IGG TEST
K010301 · Genbio · Jun 2001
K033915 · MODIFICATION TO SERAQUEST EB VCA IGG
Download PDF FDA Summary Quest Intl., Inc.