Cleared Traditional

P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN (K905385) - FDA 510(k) Clearance

Class I Microbiology device.

K905385 · Virion (U.S.), Inc. · Microbiology device
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Mar 1991
Decision
111d
Days
Class 1
Risk

K905385 is an FDA 510(k) clearance for the P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN. Classified as Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 (product code GQS), Class I - General Controls.

Submitted by Virion (U.S.), Inc. (Morristown, US). The FDA issued a Cleared decision on March 21, 1991 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3400 - 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

Submission Details

510(k) Number K905385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1990
Decision Date March 21, 1991
Days to Decision 111 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 102d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GQS Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3400
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.