Cleared Traditional

K920661 - VIDAS CMV IGG ASSAY

K920661 is an FDA 510(k) clearance for VIDAS CMV IGG ASSAY, manufactured by Vitek Systems, Inc.. The device is a Class 2 Microbiology device with product code LFZ cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K920661 · Vitek Systems, Inc. · Microbiology device
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Feb 1993
Decision
365d
Days
Class 2
Risk

K920661 is an FDA 510(k) clearance for the VIDAS CMV IGG ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 365 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 Vitek Systems, Inc. devices

FDA 510(k) Submission Details - K920661

510(k) Number K920661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1992
Decision Date February 12, 1993
Days to Decision 365 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
263d slower than avg
Panel avg: 102d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFZ Device Classification - Class 2, Special Controls

Product Code LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
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 - LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

All 50
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K920661.
OPUS CMV-G
K933389 · Pb Diagnostic Systems, Inc. · Jun 1994
BARTELS CYTOMEGALOVIRUS IGG EIA
K922582 · Baxter Diagnostics, Inc. · Apr 1993
CMV ELISA TEST SYSTEM
K924096 · Zeus Scientific, Inc. · Apr 1993
CAPTIA CMV-TA
K915479 · Mercia Diagnostics , Ltd. · May 1992
ENZYGNOST(R) ANTI-CMV IGG
K913910 · Behring Diagnostics, Inc. · Apr 1992
ENZYGNOST(R) ANTI-CMV/IGM
K913693 · Behring Diagnostics, Inc. · Feb 1992