Cleared Traditional

OXOID PYLORI TEST KIT, MODEL DR0130M (K012588) - FDA 510(k) Clearance

Class I Microbiology device.

K012588 · Oxoid , Ltd. · Microbiology device
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Dec 2001
Decision
122d
Days
Class 1
Risk

K012588 is an FDA 510(k) clearance for the OXOID PYLORI TEST KIT, MODEL DR0130M. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on December 10, 2001 after a review of 122 days - within the typical 510(k) review window.

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 Oxoid , Ltd. devices

Submission Details

510(k) Number K012588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2001
Decision Date December 10, 2001
Days to Decision 122 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 102d · This submission: 122d
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.

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