Cleared Traditional

GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT (K870176) - FDA 510(k) Clearance

Class I Microbiology device.

K870176 · Genetic Systems Corp. · Microbiology device
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Jul 1987
Decision
182d
Days
Class 1
Risk

K870176 is an FDA 510(k) clearance for the GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT. Classified as Respiratory Syncytial Virus, Antigen, Antibody, Ifa (product code LKT), Class I - General Controls.

Submitted by Genetic Systems Corp. (Seattle, US). The FDA issued a Cleared decision on July 16, 1987 after a review of 182 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3480 - 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 Genetic Systems Corp. devices

Submission Details

510(k) Number K870176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1987
Decision Date July 16, 1987
Days to Decision 182 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 102d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3480
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.