Cleared Traditional

K000155 - ELECSYS ANTI-THYROID PEROXIDASE ANTIBOD...

K000155 is the FDA 510(k) clearance for ELECSYS ANTI-THYROID PEROXIDASE ANTIBOD... by Roche Diagnostics Corp.. It is a Class 2 Immunology device (product code JZO) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K000155 · Roche Diagnostics Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
May 2000
Decision
119d
Days
Class 2
Risk

K000155 is an FDA 510(k) clearance for the ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 17, 2000 after a review of 119 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K000155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2000
Decision Date May 17, 2000
Days to Decision 119 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 104d · This submission: 119d
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 28
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K000155.
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
K033977 · Zeus Scientific, Inc. · Mar 2004
ELECSYS ANTI-TG TEST SYSTEM
K020672 · Roche Diagnostics Corp. · Aug 2002
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
K012777 · Bayer Corp. · Oct 2001
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
K000362 · Zeus Scientific, Inc. · Feb 2000
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
K991094 · Diagnostic Products Corp. · May 1999
IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
K991096 · Diagnostic Products Corp. · May 1999