Cleared Traditional

QUANTA LITE RNA POL III ELISA

K070066 · Inova Diagnostics, Inc. · Immunology
Apr 2007
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K070066 is an FDA 510(k) clearance for the QUANTA LITE RNA POL III ELISA, a Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody (Class II — Special Controls, product code NYO), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 11, 2007, 93 days after receiving the submission on January 8, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K070066 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2007
Decision Date April 11, 2007
Days to Decision 93 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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.