Cleared Traditional

K192920 - Oragene•Dx

K192920 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 90-day FDA review.

K192920 · DNA Genotek, Inc. · Chemistry device
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Jan 2020
Decision
90d
Days
Class 2
Risk

K192920 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 January 14, 2020 after a review of 90 days - within the typical 510(k) review window.

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 - K192920

510(k) Number K192920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2019
Decision Date January 14, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
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.