Cleared Special

BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT (K003204) - FDA 510(k) Clearance

Class I Microbiology device.

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.

View all Intracel Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 102d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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.