Cleared Traditional

K081746 - D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT

K081746 is an FDA 510(k) clearance for D3 DUET DFA INFLUENZA A/RESPIRATORY VIR..., manufactured by Diagnostic Hybrids, Inc.. The device is a Class 1 Microbiology device with product code GNW cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K081746 · Diagnostic Hybrids, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Dec 2008
Decision
187d
Days
Class 1
Risk

K081746 is an FDA 510(k) clearance for the D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT. Classified as Antisera, Cf, Influenza Virus A, B, C (product code GNW), 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 187 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3330 - 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

FDA 510(k) Submission Details - K081746

510(k) Number K081746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2008
Decision Date December 23, 2008
Days to Decision 187 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
85d slower than avg
Panel avg: 102d · This submission: 187d
Pathway characteristics
Predicate-based equivalence.

GNW Device Classification - Class 1, General Controls

Product Code GNW Antisera, Cf, Influenza Virus A, B, C
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3330
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 - GNW Antisera, Cf, Influenza Virus A, B, C

All 12
Devices cleared under the same product code (GNW) and FDA review panel - the closest regulatory comparables to K081746.
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
K092882 · Diagnostic Hybrids, Inc. · Oct 2009
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K092300 · Diagnostic Hybrids, Inc. · Aug 2009
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K061101 · Diagnostic Hybrids, Inc. · Nov 2006
DFA RESPIRATORY VIRUS SCREENING & ID KIT
K022713 · Diagnostic Hybrids, Inc. · Dec 2002
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
K974302 · Light Diagnostics · Apr 1998
IMAGEN RESPIRATORY SCREEN
K973954 · Dako Diagnostics , Ltd. · Dec 1997