Cleared Traditional

K141133 - 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 is an FDA 510(k) clearance for VIDAS H. pylori IgG, manufactured by BIOMERIEUX. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 434-day FDA review.

K141133 · BIOMERIEUX · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K141133

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
332d slower than avg
Panel avg: 102d · This submission: 434d
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 79
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K141133.
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
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Alere Signify H. pylori Whole Blood, Serum, Plasma
K151935 · Alere San Diego, Incorporated · Aug 2015
HELICOBACTER PYLORI ELISA IGG TEST KIT
K110745 · Gold Standard Diagnostics · Mar 2012
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
K110899 · Gold Standard Diagnostics · Feb 2012
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
K052716 · Otsuka Pharmaceutical Co., Ltd. · Nov 2006