Cleared Traditional

ImmuLisa Enhanced RNA POL III Antibody ELISA

K172078 · Immco Diagnostics, Inc. · Immunology

Mar 2018

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K172078 is an FDA 510(k) clearance for the ImmuLisa Enhanced RNA POL III Antibody ELISA, a Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody (Class II — Special Controls, product code NYO), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on March 30, 2018, 263 days after receiving the submission on July 10, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K172078 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2017
Decision Date	March 30, 2018
Days to Decision	263 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.