Cleared Traditional

ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM (K033977) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033977 · Zeus Scientific, Inc. · Immunology device
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Mar 2004
Decision
90d
Days
Class 2
Risk

K033977 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on March 22, 2004 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zeus Scientific, Inc. devices

Submission Details

510(k) Number K033977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2003
Decision Date March 22, 2004
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 104d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JZO System, Test, Thyroid Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
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 Immunology devices follow this clearance model.

Regulatory Peers - JZO System, Test, Thyroid Autoantibody

All 22
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K033977.
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
K061382 · Beckman Coulter, Inc. · Jul 2006
ROCHE ELECSYS ANTI-TG
K053426 · Roche Diagnostics Corp. · Feb 2006
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
K051890 · Roche Diagnostics Corp. · Aug 2005
ELECSYS ANTI-TG TEST SYSTEM
K020672 · Roche Diagnostics Corp. · Aug 2002
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
K000155 · Roche Diagnostics Corp. · May 2000
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
K000362 · Zeus Scientific, Inc. · Feb 2000