Cleared Traditional

K945558 - PREMIER(TM) H. PYLORY

K945558 is an FDA 510(k) clearance for PREMIER(TM) H. PYLORY, manufactured by Meridian Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K945558 · Meridian Diagnostics, Inc. · Microbiology device
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Mar 1995
Decision
109d
Days
Class 1
Risk

K945558 is an FDA 510(k) clearance for the PREMIER(TM) H. PYLORY. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 3, 1995 after a review of 109 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 Diagnostics, Inc. devices

FDA 510(k) Submission Details - K945558

510(k) Number K945558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date March 03, 1995
Days to Decision 109 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
7d slower than avg
Panel avg: 102d · This submission: 109d
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 74
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K945558.
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
K952517 · Quidel Corp. · Feb 1996
HM-CAP CONTROL PANEL
K954926 · E-Z-Em, Inc. · Jan 1996
SERIM PYLORITEK TEST KIT
K953632 · Serim Research Corp. · Dec 1995
IMMUNOCARD H. PYLORI
K941560 · Meridian Diagnostics, Inc. · Dec 1994
FLEXSURE HP
K934863 · Smithkline Diagnostics, Inc. · May 1994
UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG
K924689 · United Biotech, Inc. · Aug 1993