Cleared Traditional

K093784 - ATHENA MULTI-LYTE TORCH IGG PLUS TEST S...

K093784 is an FDA 510(k) clearance for ATHENA MULTI-LYTE TORCH IGG PLUS TEST S..., manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code OPM cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K093784 · Zeus Scientific, Inc. · Microbiology device
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Jul 2010
Decision
219d
Days
Class 2
Risk

K093784 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM. Classified as Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 (product code OPM), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on July 16, 2010 after a review of 219 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K093784

510(k) Number K093784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 102d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OPM Device Classification - Class 2, Special Controls

Product Code OPM Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.