Cleared Traditional

K022356 - NICHOLS ADVANTAGE CHEMILUMINESCENCE HEL...

K022356 is the FDA 510(k) clearance for NICHOLS ADVANTAGE CHEMILUMINESCENCE HEL... by Nichols Institute Diagnostics. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K022356 · Nichols Institute Diagnostics · Microbiology device
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Oct 2002
Decision
98d
Days
Class 1
Risk

K022356 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNO.... Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 98 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.

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Submission Details

510(k) Number K022356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2002
Decision Date October 25, 2002
Days to Decision 98 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
4d faster than avg
Panel avg: 102d · This submission: 98d
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 K022356.
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
K024360 · Alfa Scientific Designs, Inc. · Jun 2003
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
K024350 · ACON Laboratories, Inc. · Apr 2003
QUANTA LITE H.PYLORI IGA ELISA
K024334 · Inova Diagnostics, Inc. · Mar 2003
OXOID PYLORI TEST KIT, MODEL DR0130M
K012588 · Oxoid , Ltd. · Dec 2001
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
K001460 · bioMerieux, Inc. · Oct 2000
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
K000463 · Diagnostic Products Corp. · Jun 2000