Cleared Traditional

K802935 - PARAINFLUENZA 1

K802935 is the FDA 510(k) clearance for PARAINFLUENZA 1 by Orion Diagnostica, Inc.. It is a Class 1 Microbiology device (product code GQS) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K802935 · Orion Diagnostica, Inc. · Microbiology device
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Dec 1980
Decision
42d
Days
Class 1
Risk

K802935 is an FDA 510(k) clearance for the PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR. Classified as Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 (product code GQS), Class I - General Controls.

Submitted by Orion Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1980 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orion Diagnostica, Inc. devices

Submission Details

510(k) Number K802935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1980
Decision Date December 31, 1980
Days to Decision 42 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 102d · This submission: 42d
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.

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 K802935.
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K093415 · Diagnostic Hybrids, Inc. · Dec 2009
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K884193 · Baxter Diagnostics, Inc. · Nov 1988
PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT
K884194 · Baxter Diagnostics, Inc. · Nov 1988