Cleared Traditional

K012411 - HP-ONE

K012411 is an FDA 510(k) clearance for HP-ONE, manufactured by Gi Supply. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K012411 · Gi Supply · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
57d
Days
Class 1
Risk

K012411 is an FDA 510(k) clearance for the HP-ONE. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Gi Supply (Camp Hill, US). The FDA issued a Cleared decision on September 25, 2001 after a review of 57 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.

View all Gi Supply devices

FDA 510(k) Submission Details - K012411

510(k) Number K012411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2001
Decision Date September 25, 2001
Days to Decision 57 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
45d faster than avg
Panel avg: 102d · This submission: 57d
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 K012411.
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
K022356 · Nichols Institute Diagnostics · Oct 2002
PYLORITEK VP TEST KIT 5140VP
K014038 · Serim Research Corp. · Feb 2002
OXOID PYLORI TEST KIT, MODEL DR0130M
K012588 · Oxoid , Ltd. · Dec 2001
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
K001460 · bioMerieux, Inc. · Oct 2000
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
K000463 · Diagnostic Products Corp. · Jun 2000
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
K991820 · Zeus Scientific, Inc. · Aug 1999