Cleared Special

K062516 - ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)

K062516 is an FDA 510(k) clearance for ACCESS THYROGLOBULIN ANTIBODY II ASSAY, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Immunology device with product code JNL cleared through the Special 510(k) pathway after a 38-day FDA review.

K062516 · Beckman Coulter, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
38d
Days
Class 2
Risk

K062516 is an FDA 510(k) clearance for the ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (C.... Classified as Immunochemical, Thyroglobulin Autoantibody (product code JNL), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on October 5, 2006 after a review of 38 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 - K062516

510(k) Number K062516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2006
Decision Date October 05, 2006
Days to Decision 38 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
67d faster than avg
Panel avg: 105d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

JNL Device Classification - Class 2, Special Controls

Product Code JNL Immunochemical, Thyroglobulin 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 - JNL Immunochemical, Thyroglobulin Autoantibody

All 21
Devices cleared under the same product code (JNL) and FDA review panel - the closest regulatory comparables to K062516.
Access Thyroglobulin Antibody II
K240996 · Beckman Coulter, Inc. · Jul 2024
ACCESS THYROGLOBULIN ANITBODY
K112933 · Beckman Coulter, Inc. · Dec 2011
IMMUNOCAP THYRLOBULIN IMMUNOCAP
K072661 · Phadia US, Inc. · Nov 2007
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
K971834 · Monobind · Jul 1997
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
K962341 · Hycor Biomedical, Inc. · Nov 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
K962451 · Hycor Biomedical, Inc. · Nov 1996
K062516 · ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
Download PDF FDA Summary Beckman Coulter, Inc.