Cleared Special

K131804 - REMEL XPECT FLU A&B

K131804 is an FDA 510(k) clearance for REMEL XPECT FLU A&B, manufactured by Remel, Inc.. The device is a Class 1 Microbiology device with product code GNX cleared through the Special 510(k) pathway after a 23-day FDA review.

K131804 · Remel, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
23d
Days
Class 1
Risk

K131804 is an FDA 510(k) clearance for the REMEL XPECT FLU A&B. Classified as Antigens, Cf (including Cf Control), Influenza Virus A, B, C (product code GNX), Class I - General Controls.

Submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on July 12, 2013 after a review of 23 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 - K131804

510(k) Number K131804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2013
Decision Date July 12, 2013
Days to Decision 23 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
79d faster than avg
Panel avg: 102d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

GNX Device Classification - Class 1, General Controls

Product Code GNX Antigens, Cf (including Cf Control), 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 - GNX Antigens, Cf (including Cf Control), Influenza Virus A, B, C

All 13
Devices cleared under the same product code (GNX) and FDA review panel - the closest regulatory comparables to K131804.
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OSOM INFLUENZA A&B TEST MODEL 190
K123182 · SEKISUI Diagnostics, LLC · Nov 2012
K131804 · REMEL XPECT FLU A&B
Download PDF FDA Summary Remel, Inc.