Cleared Special

K003204 - BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT

K003204 is an FDA 510(k) clearance for BARTELS VIRAL RESPIRATORY SCREENING AND..., manufactured by Intracel Corp.. The device is a Class 1 Microbiology device with product code GNW cleared through the Special 510(k) pathway after a 25-day FDA review.

K003204 · Intracel Corp. · Microbiology device
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Nov 2000
Decision
25d
Days
Class 1
Risk

K003204 is an FDA 510(k) clearance for the BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT. Classified as Antisera, Cf, Influenza Virus A, B, C (product code GNW), Class I - General Controls.

Submitted by Intracel Corp. (Rockville, US). The FDA issued a Cleared decision on November 7, 2000 after a review of 25 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 - K003204

510(k) Number K003204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2000
Decision Date November 07, 2000
Days to Decision 25 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 102d · This submission: 25d
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 13
Devices cleared under the same product code (GNW) and FDA review panel - the closest regulatory comparables to K003204.
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
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
K974302 · Light Diagnostics · Apr 1998
IMAGEN RESPIRATORY SCREEN
K973954 · Dako Diagnostics , Ltd. · Dec 1997
IMAGEN RESPIRATORY SCREEN
K962037 · Dako Diagnostics , Ltd. · Dec 1996
K003204 · BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
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