Cleared Traditional

MUMPS STAT (K925209) - FDA 510(k) Clearance

Class I Microbiology device.

K925209 · Biowhittaker Molecular Applications, Inc. · Microbiology device
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Oct 1994
Decision
737d
Days
Class 1
Risk

K925209 is an FDA 510(k) clearance for the MUMPS STAT. Classified as Enzyme Linked Immunoabsorbent Assay, Mumps Virus (product code LJY), Class I - General Controls.

Submitted by Biowhittaker Molecular Applications, Inc. (Walkersville, US). The FDA issued a Cleared decision on October 14, 1994 after a review of 737 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Biowhittaker Molecular Applications, Inc. devices

Submission Details

510(k) Number K925209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1992
Decision Date October 14, 1994
Days to Decision 737 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
635d slower than avg
Panel avg: 102d · This submission: 737d
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.