Cleared Traditional

DAT TEST FOR CHAGAS' DISEASE (K834328) - FDA 510(k) Clearance

Class I Immunology device.

K834328 · Sero-Immuno Diagnostics, Inc. · Immunology device
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Mar 1984
Decision
84d
Days
Class 1
Risk

K834328 is an FDA 510(k) clearance for the DAT TEST FOR CHAGAS' DISEASE. Classified as Antigen, Latex Agglutination, T. Cruzi (product code GNE), Class I - General Controls.

Submitted by Sero-Immuno Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on March 2, 1984 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3870 - 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: 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 Sero-Immuno Diagnostics, Inc. devices

Submission Details

510(k) Number K834328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1983
Decision Date March 02, 1984
Days to Decision 84 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 104d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNE Antigen, Latex Agglutination, T. Cruzi
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3870
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.