Cleared Special

K033780 - MODIFICATION TO SERAQUEST VCA IGM

K033780 is an FDA 510(k) clearance for MODIFICATION TO SERAQUEST VCA IGM, manufactured by Quest Intl., Inc.. The device is a Class 1 Microbiology device with product code LJN cleared through the Special 510(k) pathway after a 42-day FDA review.

K033780 · 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
42d
Days
Class 1
Risk

K033780 is an FDA 510(k) clearance for the MODIFICATION TO SERAQUEST VCA IGM. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on January 15, 2004 after a review of 42 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 - K033780

510(k) Number K033780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2003
Decision Date January 15, 2004
Days to Decision 42 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
60d faster than avg
Panel avg: 102d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

LJN Device Classification - Class 1, General Controls

Product Code LJN Antibody Igm, If, Epstein-barr Virus
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 - LJN Antibody Igm, If, Epstein-barr Virus

All 23
Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K033780.
BIOPLEX 2200 EBV IGM KIT
K123021 · Bio-Rad Laboratories · Nov 2012
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
K073381 · Focus Diagnostics, Inc. · Aug 2008
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092 · Zeus Scientific, Inc. · Apr 2005
SERAQUEST EB VAC IGM
K990977 · Quest Intl., Inc. · Oct 1999
COPALIS EBV-M ANTIBODY ASSAY
K991459 · DiaSorin, Inc. · May 1999
IMMUNOWELL VCA IGM TEST
K973939 · Genbio · Aug 1998
K033780 · MODIFICATION TO SERAQUEST VCA IGM
Download PDF FDA Summary Quest Intl., Inc.