Cleared Traditional

K961508 - IMMUNOCARD H. PYLORI

K961508 is the FDA 510(k) clearance for IMMUNOCARD H. PYLORI by Meridian Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K961508 · Meridian Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
277d
Days
Class 1
Risk

K961508 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 January 21, 1997 after a review of 277 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 K961508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1996
Decision Date January 21, 1997
Days to Decision 277 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
175d slower than avg
Panel avg: 102d · This submission: 277d
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 K961508.
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
K980821 · Zeus Scientific, Inc. · Jul 1998
PREMIER PLATINUM HPSA
K980076 · Meridian Diagnostics, Inc. · May 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523 · Boehringer Mannheim Corp. · Mar 1998
VARELISA HELICOBACTER PYLORI ANTIBODIES
K953873 · Elias U.S.A., Inc. · Aug 1996
PYLORI IGG ELISA TEST SYSTEM
K961221 · Armkel, LLC · Jul 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
K960183 · Smithkline Diagnostics, Inc. · Jun 1996