Cleared Traditional

K961508 - IMMUNOCARD H. PYLORI

K961508 is an FDA 510(k) clearance for IMMUNOCARD H. PYLORI, 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 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

FDA 510(k) Submission Details - K961508

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.

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 72
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K961508.
KENLOR H. PYLORI CONTROL SERUM
K964014 · Kenlor Industries, Inc. · Mar 1997
ACCUMETER H. PYLORI TEST
K965099 · Chemtrak, Inc. · Feb 1997
H.PYLORI CONTROLS
K964675 · Pyramid Biological Corp. · Jan 1997
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
K952220 · Meretek Diagnostics, Inc. · Sep 1996
VARELISA HELICOBACTER PYLORI ANTIBODIES
K953873 · Elias U.S.A., Inc. · Aug 1996
PYLORI IGG ELISA TEST SYSTEM
K961221 · Armkel, LLC · Jul 1996