Cleared Traditional

QUANTA LITE SS-A 52 ELISA

K063565 · Inova Diagnostics, Inc. · Immunology
Apr 2007
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K063565 is an FDA 510(k) clearance for the QUANTA LITE SS-A 52 ELISA, 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 April 4, 2007, 127 days after receiving the submission on November 28, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K063565 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2006
Decision Date April 04, 2007
Days to Decision 127 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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.