Cleared Traditional

K110899 - GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT

K110899 is an FDA 510(k) clearance for GOLD STANDARD DIAGNOSTICS H. PYLORI ELI..., manufactured by Gold Standard Diagnostics. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 308-day FDA review.

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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FDA 510(k) Submission Details - K110899

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 102d · This submission: 308d
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 79
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K110899.
Alere Signify H. pylori Whole Blood, Serum, Plasma
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K141133 · BIOMERIEUX · Jul 2015
HELICOBACTER PYLORI ELISA IGG TEST KIT
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PYLO-PLUS
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