Cleared Traditional

K022713 - DFA RESPIRATORY VIRUS SCREENING & ID KIT

K022713 is the FDA 510(k) clearance for DFA RESPIRATORY VIRUS SCREENING & ID KIT by Diagnostic Hybrids, Inc.. It is a Class 1 Microbiology device (product code GNW) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K022713 · Diagnostic Hybrids, Inc. · Microbiology device
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Dec 2002
Decision
126d
Days
Class 1
Risk

K022713 is an FDA 510(k) clearance for the DFA RESPIRATORY VIRUS SCREENING & ID 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 18, 2002 after a review of 126 days - within the typical 510(k) review window.

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 K022713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2002
Decision Date December 18, 2002
Days to Decision 126 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
24d slower than avg
Panel avg: 102d · This submission: 126d
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 K022713.
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K092300 · Diagnostic Hybrids, Inc. · Aug 2009
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
K081746 · Diagnostic Hybrids, Inc. · Dec 2008
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K061101 · Diagnostic Hybrids, Inc. · Nov 2006
INFLUENZA MAB TEST/INFLUENZA A TEST
K913351 · Gull Laboratories, Inc. · Dec 1991
INFLUENZA MAB TEST/INFLUENZA B TEST
K913214 · Gull Laboratories, Inc. · Dec 1991
VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY
K896635 · Baxter Healthcare Corp · Feb 1990