Cleared Traditional

K861379 - MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) T...

K861379 is the FDA 510(k) clearance for MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) T... by Serono Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LKT) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K861379 · Serono Diagnostics, Inc. · Microbiology device
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Jul 1986
Decision
93d
Days
Class 1
Risk

K861379 is an FDA 510(k) clearance for the MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT. Classified as Respiratory Syncytial Virus, Antigen, Antibody, Ifa (product code LKT), Class I - General Controls.

Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on July 16, 1986 after a review of 93 days - within the typical 510(k) review window.

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 Serono Diagnostics, Inc. devices

Submission Details

510(k) Number K861379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1986
Decision Date July 16, 1986
Days to Decision 93 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 faster than avg
Panel avg: 102d · This submission: 93d
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.

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

All 15
Devices cleared under the same product code (LKT) and FDA review panel - the closest regulatory comparables to K861379.
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
ABBOTT RSV EIA
K852472 · Abbott Laboratories · Sep 1985
RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT
K852185 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1985
ORTHO* RSV ANTIGEN ELISA TEST SYS
K842047 · Ortho Diagnostic Systems, Inc. · Oct 1984