Cleared Traditional

K113420 - RNARETAIN (FDA 510(k) Clearance)

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

K113420 · Asuragen, Inc. · Pathology device
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Mar 2012
Decision
119d
Days
Class 2
Risk

K113420 is an FDA 510(k) clearance for the RNARETAIN. Classified as Tissue Rna Preservative For Collection, Storage, And Transportation (product code OZF), Class II - Special Controls.

Submitted by Asuragen, Inc. (Austin, US). The FDA issued a Cleared decision on March 16, 2012 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.4070 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Asuragen, Inc. devices

Submission Details

510(k) Number K113420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2011
Decision Date March 16, 2012
Days to Decision 119 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 77d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OZF Tissue Rna Preservative For Collection, Storage, And Transportation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.4070
Definition The Human Tissue Rna Preservation Collection, Storage, And Transportation Tube Is A Single-use, Prefilled Container Intended For The Collection, Storage, And Transportation Of Fresh Human Tissue Specimens For Subsequent Rna Isolation And Further Molecular Diagnostic 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 Pathology devices follow this clearance model.