Cleared Traditional

K923903 - VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA

K923903 is an FDA 510(k) clearance for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUM..., manufactured by Biomerieux Vitek, Inc.. The device is a Class 1 Microbiology device with product code LJY cleared through the Traditional 510(k) pathway after a 370-day FDA review.

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

FDA 510(k) Submission Details - K923903

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 102d · This submission: 370d
Pathway characteristics
Predicate-based equivalence.

LJY Device Classification - Class 1, General Controls

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.