Cleared Traditional

K021482 - QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
(FDA 510(k) Clearance)

K021482 · Inova Diagnostics, Inc. · Immunology
Jul 2002
Decision
83d
Days
Class 2
Risk

K021482 is an FDA 510(k) clearance for the QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA, a Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis (Class II — Special Controls, product code NIY), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on July 30, 2002, 83 days after receiving the submission on May 8, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K021482 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2002
Decision Date July 30, 2002
Days to Decision 83 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code NIY — Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660
Definition Elisa For The Detection Of Anti-sla (soluble Liver Antigen) Antibody Of The Igg Class. Intended To Aid In The Diagnosis Of Conditions With Elevated Levels Of Anti-sla Antibody Including Autoimmune Hepatitis