Cleared Traditional

K161139 - LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set

K161139 is an FDA 510(k) clearance for LIAISON H. pylori IgG, manufactured by DiaSorin, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K161139 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
91d
Days
Class 1
Risk

K161139 is an FDA 510(k) clearance for the LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on July 22, 2016 after a review of 91 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 DiaSorin, Inc. devices

FDA 510(k) Submission Details - K161139

510(k) Number K161139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2016
Decision Date July 22, 2016
Days to Decision 91 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
11d faster than avg
Panel avg: 102d · This submission: 91d
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 52
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K161139.
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
ImmunoCard STAT! HpSA
K153661 · Meridian Bioscience, Inc. · Mar 2016
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
K053335 · Meridian Bioscience, Inc. · Mar 2006
IMMUNOCARDSTAT HPSA
K032222 · Meridian Bioscience, Inc. · Dec 2003