Cleared Traditional

K041238 - HELICOBACTER PYLORI IGG ELISA

K041238 is an FDA 510(k) clearance for HELICOBACTER PYLORI IGG ELISA, manufactured by Biohit Plc. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K041238 · Biohit Plc · Microbiology device
Download Printable Device Report (PDF)
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Dec 2004
Decision
216d
Days
Class 1
Risk

K041238 is an FDA 510(k) clearance for the HELICOBACTER PYLORI IGG ELISA. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Biohit Plc (Neptune, US). The FDA issued a Cleared decision on December 13, 2004 after a review of 216 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 Biohit Plc devices

FDA 510(k) Submission Details - K041238

510(k) Number K041238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2004
Decision Date December 13, 2004
Days to Decision 216 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 102d · This submission: 216d
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 70
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K041238.
HELICOBACTER PYLORI ELISA IGG TEST KIT
K110745 · Gold Standard Diagnostics · Mar 2012
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
K110899 · Gold Standard Diagnostics · Feb 2012
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
K053335 · Meridian Bioscience, Inc. · Mar 2006
IMMUNOCARDSTAT HPSA
K032222 · Meridian Bioscience, Inc. · Dec 2003
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