Cleared Traditional

K033454 - BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN

K033454 is an FDA 510(k) clearance for BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN, manufactured by Brahms Diagnostica, LLC. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K033454 · Brahms Diagnostica, LLC · Immunology device
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Mar 2004
Decision
144d
Days
Class 2
Risk

K033454 is an FDA 510(k) clearance for the BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Brahms Diagnostica, LLC (Norcross, US). The FDA issued a Cleared decision on March 22, 2004 after a review of 144 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 Brahms Diagnostica, LLC devices

FDA 510(k) Submission Details - K033454

510(k) Number K033454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2003
Decision Date March 22, 2004
Days to Decision 144 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 105d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZO Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K033454.
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
K052308 · Fisher Diagnostics · May 2006
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ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
K051890 · Roche Diagnostics Corp. · Aug 2005
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
K033977 · Zeus Scientific, Inc. · Mar 2004
SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
K023593 · Quest Intl., Inc. · Feb 2003
ELECSYS ANTI-TG TEST SYSTEM
K020672 · Roche Diagnostics Corp. · Aug 2002