Cleared Traditional

K861379 - MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT

K861379 is an FDA 510(k) clearance for MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) T..., manufactured by Serono Diagnostics, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K861379

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 102d · This submission: 93d
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 16
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