Cleared Traditional

VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II (K141133) - FDA 510(k) Clearance

Class I Microbiology device.

K141133 · BIOMERIEUX · Microbiology device
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Jul 2015
Decision
434d
Days
Class 1
Risk

K141133 is an FDA 510(k) clearance for the VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M,.... Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by BIOMERIEUX (Hazelwood, US). The FDA issued a Cleared decision on July 9, 2015 after a review of 434 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all BIOMERIEUX devices

Submission Details

510(k) Number K141133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2014
Decision Date July 09, 2015
Days to Decision 434 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
332d slower than avg
Panel avg: 102d · This submission: 434d
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 17
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K141133.
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
K181464 · DiaSorin, Inc. · Aug 2018
H. PYLORI QUIK CHEK
K181379 · Techlab, Inc. · Aug 2018
H. PYLORI CHEK™
K181400 · Techlab, Inc. · Aug 2018
QUANTA LITE H.PYLORI IGA ELISA
K024334 · Inova Diagnostics, Inc. · Mar 2003
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