Cleared Traditional

K993585 - VARELISA TPO ANTIBODIES, MODEL 12348/12396

K993585 is an FDA 510(k) clearance for VARELISA TPO 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 75-day FDA review.

K993585 · Pharmacia & Upjohn Co. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
75d
Days
Class 2
Risk

K993585 is an FDA 510(k) clearance for the VARELISA TPO ANTIBODIES, MODEL 12348/12396. 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 January 5, 2000 after a review of 75 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 - K993585

510(k) Number K993585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1999
Decision Date January 05, 2000
Days to Decision 75 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
30d faster than avg
Panel avg: 105d · This submission: 75d
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 K993585.
VARELISA TG (THYROGLOBULIN) ANTIBODIES,
K003414 · Pharmacia & Upjohn Co. · Nov 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
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
ANTI-TPO EIA DIAGNOSTIC TEST KIT
K984163 · The Binding Site, Ltd. · Feb 1999