Cleared Traditional

K961221 - PYLORI IGG ELISA TEST SYSTEM

K961221 is an FDA 510(k) clearance for PYLORI IGG ELISA TEST SYSTEM, manufactured by Armkel, LLC. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K961221 · Armkel, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
132d
Days
Class 1
Risk

K961221 is an FDA 510(k) clearance for the PYLORI IGG ELISA TEST SYSTEM. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Armkel, LLC (Frederick, US). The FDA issued a Cleared decision on July 30, 1996 after a review of 132 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 Armkel, LLC devices

FDA 510(k) Submission Details - K961221

510(k) Number K961221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1996
Decision Date July 30, 1996
Days to Decision 132 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
30d slower than avg
Panel avg: 102d · This submission: 132d
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 K961221.
IMMUNOCARD H. PYLORI
K961508 · Meridian Diagnostics, Inc. · 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
ACCUMETER H. PYLORI TEST
K960478 · Chemtrak, Inc. · Jun 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
K960183 · Smithkline Diagnostics, Inc. · Jun 1996
HELISAL RAPID BLOOD TEST
K953686 · Cortecs, Ltd. · May 1996