Cleared Traditional

K032222 - IMMUNOCARDSTAT HPSA

K032222 is the FDA 510(k) clearance for IMMUNOCARDSTAT HPSA by Meridian Bioscience, Inc.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K032222 · Meridian Bioscience, Inc. · Microbiology device
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Dec 2003
Decision
137d
Days
Class 1
Risk

K032222 is an FDA 510(k) clearance for the IMMUNOCARDSTAT HPSA. 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 December 5, 2003 after a review of 137 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

Submission Details

510(k) Number K032222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2003
Decision Date December 05, 2003
Days to Decision 137 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
35d slower than avg
Panel avg: 102d · This submission: 137d
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 44
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K032222.
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
K161139 · DiaSorin, Inc. · Jul 2016
ImmunoCard STAT! HpSA
K153661 · Meridian Bioscience, Inc. · Mar 2016
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
K053335 · Meridian Bioscience, Inc. · Mar 2006
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
K024360 · Alfa Scientific Designs, Inc. · Jun 2003
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
K024350 · ACON Laboratories, Inc. · Apr 2003
QUANTA LITE H.PYLORI IGA ELISA
K024334 · Inova Diagnostics, Inc. · Mar 2003