Cleared Traditional

K001460 - VIDAS H. PYLORI IGG (HPY) ASSAY

K001460 is the FDA 510(k) clearance for VIDAS H. PYLORI IGG (HPY) ASSAY by bioMerieux, Inc.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K001460 · bioMerieux, Inc. · Microbiology device
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Oct 2000
Decision
147d
Days
Class 1
Risk

K001460 is an FDA 510(k) clearance for the VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by bioMerieux, Inc. (Rockland, US). The FDA issued a Cleared decision on October 4, 2000 after a review of 147 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K001460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2000
Decision Date October 04, 2000
Days to Decision 147 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 102d · This submission: 147d
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 44
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K001460.
QUANTA LITE H.PYLORI IGA ELISA
K024334 · Inova Diagnostics, Inc. · Mar 2003
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
K022356 · Nichols Institute Diagnostics · Oct 2002
OXOID PYLORI TEST KIT, MODEL DR0130M
K012588 · Oxoid , Ltd. · Dec 2001
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
QUICKVUE ONE-STEP H. PYLORI II TEST
K991747 · Quidel Corp. · Aug 1999