Cleared Traditional

ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805

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

About This 510(k) Submission

K060431 is an FDA 510(k) clearance for the ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805, a Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody (Class II — Special Controls, product code NYO), submitted by Mbl International Corporation (Deer Field, US). The FDA issued a Cleared decision on June 19, 2006, 118 days after receiving the submission on February 21, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K060431 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NYO — Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody
Device Class Class II — 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.