Cleared Traditional

K841243 - ENZYGNOST ROTAVIRUS AG

K841243 is an FDA 510(k) clearance for ENZYGNOST ROTAVIRUS AG, manufactured by Behring Diagnostics, Inc.. The device is a Class 1 Immunology device with product code LIQ cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K841243 · Behring Diagnostics, Inc. · Immunology device
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Oct 1984
Decision
208d
Days
Class 1
Risk

K841243 is an FDA 510(k) clearance for the ENZYGNOST ROTAVIRUS AG. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on October 17, 1984 after a review of 208 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3405 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K841243

510(k) Number K841243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1984
Decision Date October 17, 1984
Days to Decision 208 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 105d · This submission: 208d
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 K841243.
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
K853554 · Kallestad Laboratories, Inc. · Nov 1985
VIROGEN ROTATEST SLIDE TEST
K853399 · Armkel, LLC · Nov 1985
MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE
K850269 · Meridian Diagnostics, Inc. · Jul 1985
ROTALEX LATEX AGGLUTINATION TEST
K841319 · Orion Diagnostica, Inc. · Sep 1984