Cleared Traditional

GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT (K110899) - FDA 510(k) Clearance

Class I Microbiology device.

K110899 · Gold Standard Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
308d
Days
Class 1
Risk

K110899 is an FDA 510(k) clearance for the GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on February 1, 2012 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K110899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2011
Decision Date February 01, 2012
Days to Decision 308 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
206d slower than avg
Panel avg: 102d · This submission: 308d
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 17
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K110899.
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
K181464 · DiaSorin, Inc. · Aug 2018
H. PYLORI QUIK CHEK
K181379 · Techlab, Inc. · Aug 2018
H. PYLORI CHEK™
K181400 · Techlab, Inc. · Aug 2018
QUANTA LITE H.PYLORI IGA ELISA
K024334 · Inova Diagnostics, Inc. · Mar 2003
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