Cleared Traditional

K842047 - ORTHO* RSV ANTIGEN ELISA TEST SYS

K842047 is an FDA 510(k) clearance for ORTHO* RSV ANTIGEN ELISA TEST SYS, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 1 Microbiology device with product code LKT cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K842047 · Ortho Diagnostic Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
137d
Days
Class 1
Risk

K842047 is an FDA 510(k) clearance for the ORTHO* RSV ANTIGEN ELISA TEST SYS. Classified as Respiratory Syncytial Virus, Antigen, Antibody, Ifa (product code LKT), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 137 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 Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K842047

510(k) Number K842047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1984
Decision Date October 05, 1984
Days to Decision 137 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
35d slower than avg
Panel avg: 102d · This submission: 137d
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 K842047.
MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT
K861379 · Serono Diagnostics, Inc. · Jul 1986
ABBOTT RSV EIA
K852472 · Abbott Laboratories · Sep 1985
RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT
K852185 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1985
ORTHO RESPIRATORY SYNCYTIAL VIRUS-
K841527 · Ortho Diagnostic Systems, Inc. · Aug 1984
ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS
K831924 · Electro-Nucleonics Laboratories, Inc. · Aug 1983