Cleared Traditional

K081928 - D3 DUET DFA RSV/RESPIRATORY VIRUS SCREE...

K081928 is the FDA 510(k) clearance for D3 DUET DFA RSV/RESPIRATORY VIRUS SCREE... by Diagnostic Hybrids, Inc.. It is a Class 1 Microbiology device (product code LKT) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K081928 · Diagnostic Hybrids, Inc. · Microbiology device
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Dec 2008
Decision
169d
Days
Class 1
Risk

K081928 is an FDA 510(k) clearance for the D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT. Classified as Respiratory Syncytial Virus, Antigen, Antibody, Ifa (product code LKT), Class I - General Controls.

Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on December 23, 2008 after a review of 169 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 Hybrids, Inc. devices

Submission Details

510(k) Number K081928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2008
Decision Date December 23, 2008
Days to Decision 169 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
67d slower than avg
Panel avg: 102d · This submission: 169d
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 14
Devices cleared under the same product code (LKT) and FDA review panel - the closest regulatory comparables to K081928.
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
K983336 · Diagnostic Products Corp. · Mar 1999
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
K943317 · Diagnostic Products Corp. · Dec 1994
RSV-MAB TEST
K912842 · Gull Laboratories, Inc. · Dec 1991
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
K912838 · Baxter Diagnostics, Inc. · Sep 1991
BIOMERIEUX RSV DIRECT IF KIT
K912371 · Vitek Systems, Inc. · Sep 1991
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
K884192 · Baxter Diagnostics, Inc. · Nov 1988