Cleared Traditional

K152556 - Oragene Dx (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152556 · DNA Genotek, Inc. · Chemistry device
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May 2016
Decision
261d
Days
Class 2
Risk

K152556 is an FDA 510(k) clearance for the Oragene Dx. Classified as Dna Specimen Collection, Saliva (product code OYJ), Class II - Special Controls.

Submitted by DNA Genotek, Inc. (Ottawa, CA). The FDA issued a Cleared decision on May 26, 2016 after a review of 261 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all DNA Genotek, Inc. devices

Submission Details

510(k) Number K152556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2015
Decision Date May 26, 2016
Days to Decision 261 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 88d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OYJ Dna Specimen Collection, Saliva
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
Definition A Collection Device Intended For Use In The Non-invasive Collection Of Saliva Samples For Clinical Dna Testing.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.