Cleared Traditional

K872697 - PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN

K872697 is an FDA 510(k) clearance for PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ..., manufactured by Sita, Inc.. The device is a Class 1 Microbiology device with product code GQT cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K872697 · Sita, Inc. · Microbiology device
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Sep 1987
Decision
73d
Days
Class 1
Risk

K872697 is an FDA 510(k) clearance for the PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN. Classified as Antisera, Cf, Parainfluenza Virus 1-4 (product code GQT), Class I - General Controls.

Submitted by Sita, Inc. (Allentown, US). The FDA issued a Cleared decision on September 18, 1987 after a review of 73 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 Sita, Inc. devices

FDA 510(k) Submission Details - K872697

510(k) Number K872697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1987
Decision Date September 18, 1987
Days to Decision 73 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 102d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

GQT Device Classification - Class 1, General Controls

Product Code GQT Antisera, Cf, 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.