Cleared Traditional

ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 (K060431) - FDA 510(k) Clearance

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

K060431 · Mbl International Corporation · Immunology device
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Jun 2006
Decision
118d
Days
Class 2
Risk

K060431 is an FDA 510(k) clearance for the ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805. Classified as Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody (product code NYO), Class II - Special Controls.

Submitted by Mbl International Corporation (Deer Field, US). The FDA issued a Cleared decision on June 19, 2006 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K060431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2006
Decision Date June 19, 2006
Days to Decision 118 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 104d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NYO Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
Definition The Anti-rna Polymerase Iii Test Is A Semi-quantitative Elisa For The Detection Of Anti-rna Polymerase Iii Antibodies In Human Serum. The Test Result Is Used As An Aid In The Diagnosis Of Systemic Sclerosis (ssc) In Conjunction With The Clinical And Other Laboratory Findings. For In-vitro Diagnostic Use.
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 Immunology devices follow this clearance model.