Cleared Traditional

K924689 - UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG

K924689 is the FDA 510(k) clearance for UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG by United Biotech, Inc.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 327-day FDA review.

K924689 · United Biotech, Inc. · Microbiology device
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Aug 1993
Decision
327d
Days
Class 1
Risk

K924689 is an FDA 510(k) clearance for the UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by United Biotech, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 10, 1993 after a review of 327 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 United Biotech, Inc. devices

Submission Details

510(k) Number K924689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1992
Decision Date August 10, 1993
Days to Decision 327 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
225d slower than avg
Panel avg: 102d · This submission: 327d
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.

Regulatory Peers - LYR Helicobacter Pylori

All 45
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K924689.
PREMIER(TM) H. PYLORY
K945558 · Meridian Diagnostics, Inc. · Mar 1995
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
HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
K912255 · Hycor Biomedical, Inc. · Oct 1991