Cleared Traditional

K905306 - MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN

K905306 is an FDA 510(k) clearance for MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN, manufactured by Virion (U.S.), Inc.. The device is a Class 1 Microbiology device with product code GRC cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K905306 · Virion (U.S.), Inc. · Microbiology device
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Jun 1991
Decision
201d
Days
Class 1
Risk

K905306 is an FDA 510(k) clearance for the MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN. Classified as Antigen, Cf (including Cf Control), Mumps Virus (product code GRC), Class I - General Controls.

Submitted by Virion (U.S.), Inc. (Morristown, US). The FDA issued a Cleared decision on June 17, 1991 after a review of 201 days - an extended review cycle.

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. Standard predicate reliance. 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 Virion (U.S.), Inc. devices

FDA 510(k) Submission Details - K905306

510(k) Number K905306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date June 17, 1991
Days to Decision 201 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 102d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

GRC Device Classification - Class 1, General Controls

Product Code GRC Antigen, Cf (including Cf Control), 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.