Cleared Special

K092300 - MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT

K092300 is an FDA 510(k) clearance for MODIFICATION TO D3 ULTRA DFA RESPIRATOR..., manufactured by Diagnostic Hybrids, Inc.. The device is a Class 1 Microbiology device with product code GNW cleared through the Special 510(k) pathway after a 30-day FDA review.

K092300 · Diagnostic Hybrids, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
30d
Days
Class 1
Risk

K092300 is an FDA 510(k) clearance for the MODIFICATION TO D3 ULTRA 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 August 28, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3330 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K092300

510(k) Number K092300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2009
Decision Date August 28, 2009
Days to Decision 30 days
Submission Type Special
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
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 15
Devices cleared under the same product code (GNW) and FDA review panel - the closest regulatory comparables to K092300.
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
K092882 · Diagnostic Hybrids, Inc. · Oct 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
DFA RESPIRATORY VIRUS SCREENING & ID KIT
K022713 · Diagnostic Hybrids, Inc. · Dec 2002
BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
K003204 · Intracel Corp. · Nov 2000
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
K974302 · Light Diagnostics · Apr 1998
K092300 · MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
Download PDF FDA Summary Diagnostic Hybrids, I…