Cleared Traditional

K000155 - ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM

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

K000155 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K000155

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
14d slower than avg
Panel avg: 105d · This submission: 119d
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 67
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K000155.
ALPCO MILENIA ANTI-TPO ELISA
K011201 · American Laboratory Products Co., Ltd. · May 2001
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
K003291 · Bayer Diagnostics Corp. · Dec 2000
VARELISA TG (THYROGLOBULIN) ANTIBODIES,
K003414 · Pharmacia & Upjohn Co. · Nov 2000
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
K000362 · Zeus Scientific, Inc. · Feb 2000
VARELISA TPO ANTIBODIES, MODEL 12348/12396
K993585 · Pharmacia & Upjohn Co. · Jan 2000
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
K991094 · Diagnostic Products Corp. · May 1999