Cleared Traditional

K943317 - PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)

K943317 is the FDA 510(k) clearance for PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) by Diagnostic Products Corp.. It is a Class 1 Microbiology device (product code LKT) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K943317 · Diagnostic Products Corp. · Microbiology device
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Dec 1994
Decision
161d
Days
Class 1
Risk

K943317 is an FDA 510(k) clearance for the PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV). Classified as Respiratory Syncytial Virus, Antigen, Antibody, Ifa (product code LKT), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 19, 1994 after a review of 161 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K943317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1994
Decision Date December 19, 1994
Days to Decision 161 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 102d · This submission: 161d
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 10
Devices cleared under the same product code (LKT) and FDA review panel - the closest regulatory comparables to K943317.
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
K983336 · Diagnostic Products Corp. · Mar 1999
RSV-MAB TEST
K912842 · Gull Laboratories, Inc. · Dec 1991
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
K912838 · Baxter Diagnostics, Inc. · Sep 1991
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