Cleared Traditional

K915185 - GAP IGG H.PYLORI MODIFIED (FDA 510(k) Clearance)

Class I Microbiology device.

K915185 · Biomerica, Inc. · Microbiology device
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Mar 1992
Decision
107d
Days
Class 1
Risk

K915185 is an FDA 510(k) clearance for the GAP IGG H.PYLORI MODIFIED. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on March 4, 1992 after a review of 107 days - within the typical 510(k) review window.

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 Biomerica, Inc. devices

Submission Details

510(k) Number K915185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1991
Decision Date March 04, 1992
Days to Decision 107 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
5d slower than avg
Panel avg: 102d · This submission: 107d
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.