Cleared Traditional

K192817 - Curian HpSA

K192817 is an FDA 510(k) clearance for Curian HpSA, 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 164-day FDA review.

K192817 · Meridian Bioscience, Inc. · Microbiology device
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Mar 2020
Decision
164d
Days
Class 1
Risk

K192817 is an FDA 510(k) clearance for the Curian HpSA, Curian Analyzer. 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 March 13, 2020 after a review of 164 days - an extended review 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: 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 - K192817

510(k) Number K192817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2019
Decision Date March 13, 2020
Days to Decision 164 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
62d slower than avg
Panel avg: 102d · This submission: 164d
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 K192817.
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Vstrip H. pylori Antigen Rapid Test
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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