Cleared Traditional

K915185 - GAP IGG H.PYLORI MODIFIED

K915185 is an FDA 510(k) clearance for GAP IGG H.PYLORI MODIFIED, manufactured by Biomerica, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 107-day FDA review.

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

FDA 510(k) Submission Details - K915185

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.

LYR Device Classification - Class 1, General Controls

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.

Regulatory Peers - LYR Helicobacter Pylori

All 51
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K915185.
IMMUNOCARD H. PYLORI
K941560 · Meridian Diagnostics, Inc. · Dec 1994
FLEXSURE HP
K934863 · Smithkline Diagnostics, Inc. · May 1994
PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED
K923445 · Hycor Biomedical, Inc. · Sep 1992
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
K915851 · Quidel Corp. · Feb 1992
PYLORISET
K904655 · Orion Diagnostica, Inc. · Oct 1991
HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
K912255 · Hycor Biomedical, Inc. · Oct 1991