Cleared Traditional

K110701 - ORAGENE-DX OGD-500 (FDA 510(k) Clearance)

Also includes:
ORAGENE-DX OGD-575 ORAGENE-DX OXD-525 ORAGENE-DX OYD-500

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

K110701 · DNA Genotek, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
263d
Days
Class 2
Risk

K110701 is an FDA 510(k) clearance for the ORAGENE-DX OGD-500. Classified as Dna Specimen Collection, Saliva (product code OYJ), Class II - Special Controls.

Submitted by DNA Genotek, Inc. (Ottawa Ontario, CA). The FDA issued a Cleared decision on December 2, 2011 after a review of 263 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 K110701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2011
Decision Date December 02, 2011
Days to Decision 263 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
175d slower than avg
Panel avg: 88d · This submission: 263d
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.