Cleared Traditional

K110745 - HELICOBACTER PYLORI ELISA IGG TEST KIT (FDA 510(k) Clearance)

Class I Microbiology device.

K110745 · Gold Standard Diagnostics · Microbiology device
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Optimized for regulatory review, auditing and printing
Mar 2012
Decision
351d
Days
Class 1
Risk

K110745 is an FDA 510(k) clearance for the HELICOBACTER PYLORI ELISA IGG 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 March 2, 2012 after a review of 351 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 K110745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2011
Decision Date March 02, 2012
Days to Decision 351 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
249d slower than avg
Panel avg: 102d · This submission: 351d
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.