Cleared Traditional

QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS

K141655 · Inova Diagnostics, Inc. · Immunology

Mar 2015

Decision

258d

Days

Class 2

Risk

About This 510(k) Submission

K141655 is an FDA 510(k) clearance for the QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS, a Anti-ss-a 52 Autoantibodies (Class II — Special Controls, product code OBE), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on March 5, 2015, 258 days after receiving the submission on June 20, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K141655 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2014
Decision Date	March 05, 2015
Days to Decision	258 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	OBE — Anti-ss-a 52 Autoantibodies
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5100
Definition	The Device Is Used For The Detection, In Human Serum Or Plasma, Of Autoantibodies To Ss-a 52. The Detection Of Ss-a 52 Autoantibodies May Aid In The Diagnosis Of Systemic Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis And Dermatomyositis.