Cleared Traditional

K870176 - GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT

K870176 is an FDA 510(k) clearance for GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE ..., manufactured by Genetic Systems Corp.. The device is a Class 1 Microbiology device with product code LKT cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K870176 · Genetic Systems Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K870176

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.

LKT Device Classification - Class 1, General Controls

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.

Regulatory Peers - LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa

All 17
Devices cleared under the same product code (LKT) and FDA review panel - the closest regulatory comparables to K870176.
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
K884192 · Baxter Diagnostics, Inc. · Nov 1988
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST
K882687 · Gull Laboratories, Inc. · Aug 1988
RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE
K872082 · Medical Diagnostic Technologies, Inc. · Jul 1987
CELLMATICS RSV DETECTION SYSTEM
K862321 · Difco Laboratories, Inc. · Aug 1986
MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT
K861379 · Serono Diagnostics, Inc. · Jul 1986
ABBOTT RSV EIA
K852472 · Abbott Laboratories · Sep 1985