Cleared Traditional

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA (K923903) - FDA 510(k) Clearance

Class I Microbiology device.

K923903 · Biomerieux Vitek, Inc. · Microbiology device
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Aug 1993
Decision
370d
Days
Class 1
Risk

K923903 is an FDA 510(k) clearance for the VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA. Classified as Enzyme Linked Immunoabsorbent Assay, Mumps Virus (product code LJY), Class I - General Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3380 - 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

Submission Details

510(k) Number K923903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1992
Decision Date August 09, 1993
Days to Decision 370 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
268d slower than avg
Panel avg: 102d · This submission: 370d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3380
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.