Cleared Traditional

EliA RNA Pol III

K202541 · Phadia AB · Immunology

Sep 2021

Decision

376d

Days

Class 2

Risk

About This 510(k) Submission

K202541 is an FDA 510(k) clearance for the EliA RNA Pol III, a Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody (Class II — Special Controls, product code NYO), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on September 13, 2021, 376 days after receiving the submission on September 2, 2020. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K202541 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2020
Decision Date	September 13, 2021
Days to Decision	376 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.