Cleared Traditional

K933716 - ABBOTT CHAGAS ANTIBODY EIA (FDA 510(k) Clearance)

Class I Microbiology device.

K933716 · Abbott Laboratories · Microbiology device
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Dec 1994
Decision
507d
Days
Class 1
Risk

K933716 is an FDA 510(k) clearance for the ABBOTT CHAGAS ANTIBODY EIA. Classified as Enzyme Linked Immunosorbent Assay, T. Cruzi (product code MIU), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 19, 1994 after a review of 507 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3870 - 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: 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 Microbiology submissions.

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Submission Details

510(k) Number K933716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1993
Decision Date December 19, 1994
Days to Decision 507 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
405d slower than avg
Panel avg: 102d · This submission: 507d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MIU Enzyme Linked Immunosorbent Assay, 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.