Cleared Traditional

PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 (K983336) - FDA 510(k) Clearance

Class I Microbiology device.

K983336 · Diagnostic Products Corp. · Microbiology device
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Mar 1999
Decision
176d
Days
Class 1
Risk

K983336 is an FDA 510(k) clearance for the PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1. 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 March 18, 1999 after a review of 176 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.

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Submission Details

510(k) Number K983336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1998
Decision Date March 18, 1999
Days to Decision 176 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 102d · This submission: 176d
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.