Cleared Traditional

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (K181464) - FDA 510(k) Clearance

Class I Microbiology device.

K181464 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
88d
Days
Class 1
Risk

K181464 is an FDA 510(k) clearance for the LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen 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 August 31, 2018 after a review of 88 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 DiaSorin, Inc. devices

Submission Details

510(k) Number K181464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2018
Decision Date August 31, 2018
Days to Decision 88 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
14d faster than avg
Panel avg: 102d · This submission: 88d
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.

Clinical Evidence

ClinicalTrials.gov
NCT03060733 Completed Observational Industry-sponsored

Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

Helicobacter Pylori Sample Collection Protocol POST-THERAPY

13
Patients (actual)
5
Sites
Condition studied Helicobacter Pylori Infection; Gastric Ulcer; Nausea; Abdominal Pain; Weight Loss; Stomach Ulcer; Loss of Appetite; Bloating
Eligibility All sexes · 22 Years+
Sponsor DiaSorin Inc. (industry)
Started 2017-02-14 → Primary completion 2018-05-14
Primary outcome
Helicobacter pylori Stool Collection
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - LYR Helicobacter Pylori

All 27
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K181464.
Curian HpSA, Curian Analyzer
K192817 · Meridian Bioscience, Inc. · Mar 2020
Vstrip H. pylori Antigen Rapid Test
K183573 · Panion & BF Biotech, Inc. · Mar 2019
PREMIER Platinum HpSA PLUS
K182559 · Meridian Bioscience, Inc. · Nov 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