Cleared Traditional

K843367 - ROTAVIRUS ENZYME IMMUNOASSAY

K843367 is an FDA 510(k) clearance for ROTAVIRUS ENZYME IMMUNOASSAY, manufactured by Intl. Diagnostic Laboratories, Ltd.. The device is a Class 1 Immunology device with product code LIQ cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K843367 · Intl. Diagnostic Laboratories, Ltd. · Immunology device
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Jun 1985
Decision
289d
Days
Class 1
Risk

K843367 is an FDA 510(k) clearance for the ROTAVIRUS ENZYME IMMUNOASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Intl. Diagnostic Laboratories, Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 13, 1985 after a review of 289 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 Intl. Diagnostic Laboratories, Ltd. devices

FDA 510(k) Submission Details - K843367

510(k) Number K843367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date June 13, 1985
Days to Decision 289 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 105d · This submission: 289d
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 28
Devices cleared under the same product code (LIQ) and FDA review panel - the closest regulatory comparables to K843367.
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
ENZYGNOST ROTAVIRUS AG
K841243 · Behring Diagnostics, Inc. · Oct 1984
ROTALEX LATEX AGGLUTINATION TEST
K841319 · Orion Diagnostica, Inc. · Sep 1984