Cleared Traditional

K081746 - D3 DUET DFA INFLUENZA A/RESPIRATORY VIR...

K081746 is the FDA 510(k) clearance for D3 DUET DFA INFLUENZA A/RESPIRATORY VIR... by Diagnostic Hybrids, Inc.. It is a Class 1 Microbiology device (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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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

Submission Details

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.

Device Classification

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 7
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
INFLUENZA MAB TEST/INFLUENZA A TEST
K913351 · Gull Laboratories, Inc. · Dec 1991
INFLUENZA MAB TEST/INFLUENZA B TEST
K913214 · Gull Laboratories, Inc. · Dec 1991