Cleared Traditional

K182559 - PREMIER Platinum HpSA PLUS (FDA 510(k) Clearance)

Class I Microbiology device.

K182559 · Meridian Bioscience, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
49d
Days
Class 1
Risk

K182559 is an FDA 510(k) clearance for the PREMIER Platinum HpSA PLUS. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 5, 2018 after a review of 49 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 Meridian Bioscience, Inc. devices

Submission Details

510(k) Number K182559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2018
Decision Date November 05, 2018
Days to Decision 49 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
53d faster than avg
Panel avg: 102d · This submission: 49d
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 90
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K182559.
Hp Detect™ Stool Antigen ELISA
K232892 · Biomerica, Inc. · Dec 2023
Premier HpSA Flex (619096)
K230901 · Meridian Bioscience, Inc. · Jul 2023
Curian HpSA, Curian Analyzer
K192817 · Meridian Bioscience, Inc. · Mar 2020
Vstrip H. pylori Antigen Rapid Test
K183573 · Panion & BF Biotech, Inc. · Mar 2019
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
K181464 · DiaSorin, Inc. · Aug 2018
H. PYLORI QUIK CHEK
K181379 · Techlab, Inc. · Aug 2018