Cleared Traditional

K183573 - Vstrip H. pylori Antigen Rapid Test (FDA 510(k) Clearance)

Class I Microbiology device.

K183573 · Panion & BF Biotech, Inc. · Microbiology device
Mar 2019
Decision
83d
Days
Class 1
Risk

K183573 is an FDA 510(k) clearance for the Vstrip H. pylori Antigen Rapid Test. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Panion & BF Biotech, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on March 14, 2019 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K183573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2018
Decision Date March 14, 2019
Days to Decision 83 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 174d · This submission: 83d
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.