Cleared Special

K112933 - ACCESS THYROGLOBULIN ANITBODY

K112933 is the FDA 510(k) clearance for ACCESS THYROGLOBULIN ANITBODY by Beckman Coulter, Inc.. It is a Class 2 Immunology device (product code JNL) cleared through the Special 510(k) pathway after a 85-day FDA review.

K112933 · Beckman Coulter, Inc. · Immunology device
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Dec 2011
Decision
85d
Days
Class 2
Risk

K112933 is an FDA 510(k) clearance for the ACCESS THYROGLOBULIN ANITBODY. 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 December 27, 2011 after a review of 85 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.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K112933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date December 27, 2011
Days to Decision 85 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
19d faster than avg
Panel avg: 104d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

Devices cleared under the same product code (JNL) and FDA review panel - the closest regulatory comparables to K112933.
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
K250816 · Siemens Healthcare Diagnostics, Inc. · Dec 2025
Access Thyroglobulin Antibody II
K240996 · Beckman Coulter, Inc. · Jul 2024
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
K062516 · Beckman Coulter, Inc. · Oct 2006
AURAFLEX TG-AB AND TPO-AB
K951320 · Organon Teknika Corp. · Aug 1995
AURAFLEX TPO-AB
K952607 · Organon Teknika Corp. · Aug 1995
SYNELISA TPO ANTIBODIES
K921787 · Elias U.S.A., Inc. · Jul 1992