Cleared Traditional

K905409 - EIA FOR DETECTION OF ANTIBODIES H. PYLORI (FDA 510(k) Clearance)

Class I Microbiology device.

K905409 · E-Z-Em, Inc. · Microbiology device
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Jun 1991
Decision
189d
Days
Class 1
Risk

K905409 is an FDA 510(k) clearance for the EIA FOR DETECTION OF ANTIBODIES H. PYLORI. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by E-Z-Em, Inc. (North Caldwell, US). The FDA issued a Cleared decision on June 10, 1991 after a review of 189 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all E-Z-Em, Inc. devices

Submission Details

510(k) Number K905409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1990
Decision Date June 10, 1991
Days to Decision 189 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 102d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYR Helicobacter Pylori
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
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.