Cleared Traditional

AMIZYME-SCHISTOSOMA SPP. TEST KIT (K842527) - FDA 510(k) Clearance

Class I Microbiology device.

K842527 · Amico Lab, Inc. · Microbiology device
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Sep 1984
Decision
69d
Days
Class 1
Risk

K842527 is an FDA 510(k) clearance for the AMIZYME-SCHISTOSOMA SPP. TEST KIT. Classified as Antigen, Fluorescent Antibody Test, Schistosoma Mansoni (product code GNH), Class I - General Controls.

Submitted by Amico Lab, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 5, 1984 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3600 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amico Lab, Inc. devices

Submission Details

510(k) Number K842527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1984
Decision Date September 05, 1984
Days to Decision 69 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 102d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNH Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3600
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.