Cleared Traditional

K003414 - VARELISA TG (THYROGLOBULIN) ANTIBODIES,

K003414 is an FDA 510(k) clearance for VARELISA TG (THYROGLOBULIN) ANTIBODIES, manufactured by Pharmacia & Upjohn Co.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K003414 · Pharmacia & Upjohn Co. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
25d
Days
Class 2
Risk

K003414 is an FDA 510(k) clearance for the VARELISA TG (THYROGLOBULIN) ANTIBODIES,. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Pharmacia & Upjohn Co. (Westervillle, US). The FDA issued a Cleared decision on November 27, 2000 after a review of 25 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pharmacia & Upjohn Co. devices

FDA 510(k) Submission Details - K003414

510(k) Number K003414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2000
Decision Date November 27, 2000
Days to Decision 25 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
80d faster than avg
Panel avg: 105d · This submission: 25d
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 K003414.
ALPCO MILENIA ANTI-TG EIA
K011415 · American Laboratory Products Co., Ltd. · May 2001
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
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
VARELISA TPO ANTIBODIES, MODEL 12348/12396
K993585 · Pharmacia & Upjohn Co. · Jan 2000