Cleared Special

K991096 - IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06

K991096 is an FDA 510(k) clearance for IMMULITE 2000 ANTI-TPO AB, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code JZO cleared through the Special 510(k) pathway after a 42-day FDA review.

K991096 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
42d
Days
Class 2
Risk

K991096 is an FDA 510(k) clearance for the IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06. 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 May 13, 1999 after a review of 42 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K991096

510(k) Number K991096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1999
Decision Date May 13, 1999
Days to Decision 42 days
Submission Type Special
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
63d faster than avg
Panel avg: 105d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

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 89
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K991096.
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG
K992790 · Brahms Diagnostica, LLC · Nov 1999
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
K992791 · Brahms Diagnostica, LLC · Nov 1999
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
K991094 · Diagnostic Products Corp. · May 1999
ANTI-TPO EIA DIAGNOSTIC TEST KIT
K984163 · The Binding Site, Ltd. · Feb 1999
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT
K984165 · The Binding Site, Ltd. · Feb 1999
IS ANTI-TPO IGG ELISA TEST SYSTEM
K984228 · Columbia Bioscience, Inc. · Feb 1999
K991096 · IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
Download PDF FDA Summary Diagnostic Products C…