Cleared Traditional

ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM

K093784 · Zeus Scientific, Inc. · Microbiology

Jul 2010

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K093784 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM, a Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 (Class II — Special Controls, product code OPM), submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on July 16, 2010, 219 days after receiving the submission on December 9, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number	K093784 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2009
Decision Date	July 16, 2010
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OPM — Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3510
Definition	The Test Is A Multiplex Immunoassay Intended For The Qualitative Detection Of Specific Human Igg Antibodies To Toxoplasma Gondii (t.gondii), Rubella, Cytomegalovirus (cmv) And Herpes Simplex Virus 1 & 2 (hsv 1 And Hsv 2) In Human Serum. The Results Of This Assay Are Intended To Be Used As An Aid In The Assessment Of A Patient's Serological Status To Toxoplasma Gondii, Rubella, Cmv And Hsv 1 & 2. The Test Is Not Intended For Use In Screening Blood Or Plasma Donors.