Cleared Traditional

AMIZYME-EBV TEST KIT (K842530) - FDA 510(k) Clearance

Class I Immunology device.

K842530 · Amico Lab, Inc. · Immunology device
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Dec 1985
Decision
526d
Days
Class 1
Risk

K842530 is an FDA 510(k) clearance for the AMIZYME-EBV TEST KIT. Classified as Antiserum, Cf, Epstein-barr Virus (product code GNP), Class I - General Controls.

Submitted by Amico Lab, Inc.. The FDA issued a Cleared decision on December 6, 1985 after a review of 526 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3235 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Amico Lab, Inc. devices

Submission Details

510(k) Number K842530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1984
Decision Date December 06, 1985
Days to Decision 526 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
422d slower than avg
Panel avg: 104d · This submission: 526d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNP Antiserum, Cf, Epstein-barr Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
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.