Cleared Traditional

K941560 - IMMUNOCARD H. PYLORI (FDA 510(k) Clearance)

Class I Microbiology device.

K941560 · Meridian Diagnostics, Inc. · Microbiology device
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Dec 1994
Decision
251d
Days
Class 1
Risk

K941560 is an FDA 510(k) clearance for the IMMUNOCARD H. PYLORI. 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 December 8, 1994 after a review of 251 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 Diagnostics, Inc. devices

Submission Details

510(k) Number K941560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1994
Decision Date December 08, 1994
Days to Decision 251 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 102d · This submission: 251d
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.