Cleared Traditional

K152556 - Oragene Dx

K152556 is an FDA 510(k) clearance for Oragene Dx, manufactured by DNA Genotek, Inc.. The device is a Class 2 Chemistry device with product code OYJ cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K152556 · DNA Genotek, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K152556

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.

OYJ Device Classification - Class 2, Special Controls

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.