Cleared Traditional

K905385 - P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN

K905385 is an FDA 510(k) clearance for P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN, manufactured by Virion (U.S.), Inc.. The device is a Class 1 Microbiology device with product code GQS cleared through the Traditional 510(k) pathway after a 111-day FDA review.

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

FDA 510(k) Submission Details - K905385

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.

GQS Device Classification - Class 1, General Controls

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.

Regulatory Peers - GQS Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4

Devices cleared under the same product code (GQS) and FDA review panel - the closest regulatory comparables to K905385.
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