Cleared Traditional

K963695 - IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ

K963695 is an FDA 510(k) clearance for IMMULITE ANTI-TPO-AB(LKTOI, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K963695 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
123d
Days
Class 2
Risk

K963695 is an FDA 510(k) clearance for the IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on January 17, 1997 after a review of 123 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K963695

510(k) Number K963695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date January 17, 1997
Days to Decision 123 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
18d slower than avg
Panel avg: 105d · This submission: 123d
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 71
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K963695.
UNICAP THYROID PEROXIDASE IGG
K981930 · Pharmacia & Upjohn Co. · Jul 1998
IMMULITE ANTI-TG AB
K980206 · Diagnostic Products Corp. · May 1998
THYROGLOBULIN ASSAY SYSTEM
K972190 · American Laboratory Products Co., Ltd. · Jul 1997
THYROID PEROXIDASE ANTIBODY ELISA
K960369 · Immco Diagnostics, Inc. · Jun 1996
THYROGLOBULIN ANTIBODY ELISA
K960370 · Immco Diagnostics, Inc. · Jun 1996
DIASTAT ANTI-THYROID PEROXIDASE KIT
K951487 · Shield Diagnostics, Ltd. · Jun 1995