Cleared Traditional

K853399 - VIROGEN ROTATEST SLIDE TEST

K853399 is an FDA 510(k) clearance for VIROGEN ROTATEST SLIDE TEST, manufactured by Armkel, LLC. The device is a Class 1 Microbiology device with product code LIQ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K853399 · Armkel, LLC · Microbiology device
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Nov 1985
Decision
92d
Days
Class 1
Risk

K853399 is an FDA 510(k) clearance for the VIROGEN ROTATEST SLIDE TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on November 12, 1985 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3405 - 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 Armkel, LLC devices

FDA 510(k) Submission Details - K853399

510(k) Number K853399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date November 12, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 102d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

LIQ Device Classification - Class 1, General Controls

Product Code LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3405
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 - LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus

All 27
Devices cleared under the same product code (LIQ) and FDA review panel - the closest regulatory comparables to K853399.
ROTALEX
K860529 · Orion Corp. · Mar 1986
ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
K854129 · Orion Diagnostica, Inc. · Jan 1986
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
K853554 · Kallestad Laboratories, Inc. · Nov 1985
MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE
K850269 · Meridian Diagnostics, Inc. · Jul 1985
ENZYGNOST ROTAVIRUS AG
K841243 · Behring Diagnostics, Inc. · Oct 1984
ROTALEX LATEX AGGLUTINATION TEST
K841319 · Orion Diagnostica, Inc. · Sep 1984