Cleared Traditional

K933549 - VIDAS CMV IGM ASSAY

K933549 is an FDA 510(k) clearance for VIDAS CMV IGM ASSAY, manufactured by Biomerieux Vitek, Inc.. The device is a Class 2 Microbiology device with product code LKQ cleared through the Traditional 510(k) pathway after a 376-day FDA review.

K933549 · Biomerieux Vitek, Inc. · Microbiology device
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Aug 1994
Decision
376d
Days
Class 2
Risk

K933549 is an FDA 510(k) clearance for the VIDAS CMV IGM ASSAY. Classified as Antibody Igm,if, Cytomegalovirus Virus (product code LKQ), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on August 2, 1994 after a review of 376 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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. Elevated predicate reliance profile. 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 Biomerieux Vitek, Inc. devices

FDA 510(k) Submission Details - K933549

510(k) Number K933549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1993
Decision Date August 02, 1994
Days to Decision 376 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
274d slower than avg
Panel avg: 102d · This submission: 376d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKQ Device Classification - Class 2, Special Controls

Product Code LKQ Antibody Igm,if, Cytomegalovirus Virus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LKQ Antibody Igm,if, Cytomegalovirus Virus

All 15
Devices cleared under the same product code (LKQ) and FDA review panel - the closest regulatory comparables to K933549.
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
K100433 · Siemens Healthcare Diagnostics · May 2010
ACCURUN 146 CMV IGM POSITIVE CONTROL
K972884 · Boston Biomedica, Inc. · Aug 1997
BARTELS CYTOMEGALOVIRUS IGM EIA
K922580 · Baxter Diagnostics, Inc. · Apr 1993
ELISA CMV IGM
K914789 · Sclavo, Inc. · Mar 1992
CMV-IGM IFA TEST SYSTEM
K900743 · Zeus Scientific, Inc. · Apr 1990
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893465 · Immuno Concepts, Inc. · Jul 1989