Cleared Traditional

K024360 - INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST

K024360 is an FDA 510(k) clearance for INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST, manufactured by Alfa Scientific Designs, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K024360 · Alfa Scientific Designs, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
162d
Days
Class 1
Risk

K024360 is an FDA 510(k) clearance for the INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on June 10, 2003 after a review of 162 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 Alfa Scientific Designs, Inc. devices

FDA 510(k) Submission Details - K024360

510(k) Number K024360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2002
Decision Date June 10, 2003
Days to Decision 162 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
60d slower than avg
Panel avg: 102d · This submission: 162d
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 K024360.
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
K053335 · Meridian Bioscience, Inc. · Mar 2006
HELICOBACTER PYLORI IGG ELISA
K041238 · Biohit Plc · Dec 2004
IMMUNOCARDSTAT HPSA
K032222 · Meridian Bioscience, Inc. · Dec 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
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
K022356 · Nichols Institute Diagnostics · Oct 2002