Cleared Traditional

ROTAVIRUS ENZYME IMMUNOASSAY (K843367) - FDA 510(k) Clearance

Class I Immunology device.

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

Submission Details

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
185d slower than avg
Panel avg: 104d · This submission: 289d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.