Cleared Traditional

K024360 - INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K024360 · Alfa Scientific Designs, Inc. · Microbiology device
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Jun 2003
Decision
162d
Days
Class 1
Risk

K024360 is an FDA 510(k) clearance for the INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on June 10, 2003 after a review of 162 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 Alfa Scientific Designs, Inc. devices

Submission Details

510(k) Number K024360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2002
Decision Date June 10, 2003
Days to Decision 162 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
60d slower than avg
Panel avg: 102d · This submission: 162d
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.