Cleared Traditional

K230901 - Premier HpSA Flex (619096)

K230901 is an FDA 510(k) clearance for Premier HpSA Flex (619096), manufactured by Meridian Bioscience, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K230901 · Meridian Bioscience, Inc. · Microbiology device
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Jul 2023
Decision
94d
Days
Class 1
Risk

K230901 is an FDA 510(k) clearance for the Premier HpSA Flex (619096). 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 July 3, 2023 after a review of 94 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 Meridian Bioscience, Inc. devices

FDA 510(k) Submission Details - K230901

510(k) Number K230901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2023
Decision Date July 03, 2023
Days to Decision 94 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
8d faster than avg
Panel avg: 102d · This submission: 94d
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 72
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K230901.
Hp Detect™ Stool Antigen ELISA
K232892 · Biomerica, Inc. · Dec 2023
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
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
K181464 · DiaSorin, Inc. · Aug 2018
H. PYLORI QUIK CHEK
K181379 · Techlab, Inc. · Aug 2018