Product Code: JNL FDA class 2 21 CFR 866.5870

Immunochemical, Thyroglobulin Autoantibody

Immunology

The Immunochemical, Thyroglobulin Autoantibody test is an in vitro diagnostic device used in immunology to detect and measure autoantibodies against thyroglobulin, a protein involved in thyroid hormone synthesis, in patient serum. Detection of these autoantibodies aids in the diagnosis and monitoring of autoimmune thyroid diseases such as Hashimoto's thyroiditis and Graves' disease. This device is FDA Class 2, a moderate risk designation that requires 510(k) premarket notification to demonstrate substantial equivalence before marketing. It carries product code JNL and is regulated under 21 CFR 866.5870, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.

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Basic Information

Product Code: JNL
Device Class: FDA class 2
Regulation Number: 866.5870
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250816	ADVIA Centaur Anti-Thyroglobulin II (aTgII)	Dec 04, 2025	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K240996	Access Thyroglobulin Antibody II	Jul 03, 2024	Substantially Equivalent	Beckman Coulter, Inc.
K112933	ACCESS THYROGLOBULIN ANITBODY	Dec 27, 2011	Substantially Equivalent	Beckman Coulter, Inc.
K072661	IMMUNOCAP THYRLOBULIN IMMUNOCAP	Nov 20, 2007	Substantially Equivalent	Phadia US, Inc.
K062516	ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)	Oct 05, 2006	Substantially Equivalent	Beckman Coulter, Inc.
K971834	ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA	Jul 03, 1997	Substantially Equivalent	Monobind
K962451	HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)	Nov 25, 1996	Substantially Equivalent	Hycor Biomedical, Inc.
K962341	HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)	Nov 25, 1996	Substantially Equivalent	Hycor Biomedical, Inc.
K954256	ANTI-TPO	Nov 27, 1995	Substantially Equivalent	Biomerica, Inc.
K951364	MICROSOMAL EIA TEST KIT	Nov 20, 1995	Substantially Equivalent	Immunoprobe, Inc.
K951362	THYROGLOBULIN EIA TEST KIT	Nov 20, 1995	Substantially Equivalent	Immunoprobe, Inc.
K952607	AURAFLEX TPO-AB	Aug 25, 1995	Substantially Equivalent	Organon Teknika Corp.
K951320	AURAFLEX TG-AB AND TPO-AB	Aug 25, 1995	Substantially Equivalent	Organon Teknika Corp.
K943580	AUTOSTAT II ANTI-TPO	Apr 17, 1995	Substantially Equivalent	Cogent Diagnotics , Ltd.
K941361	MICROSOMAL EIA TEST KIT	May 11, 1994	Substantially Equivalent	Immunoprobe, Inc.
K941358	THYROGLOBULIN EIA TEST KIT	May 11, 1994	Substantially Equivalent	Immunoprobe, Inc.
K930777	THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT	Apr 08, 1993	Substantially Equivalent	Nichols Institute
K923371	AUTOSTAT ANTI-THYROID MICROSSOMAL	Sep 22, 1992	Substantially Equivalent	Cogent Diagnotics , Ltd.
K923370	AUTOSTAT ANTI-THYROGLOBULIN	Sep 22, 1992	Substantially Equivalent	Cogent Diagnotics , Ltd.
K921787	SYNELISA TPO ANTIBODIES	Jul 28, 1992	Substantially Equivalent	Elias U.S.A., Inc.
K905486	IMMUNOWELL TPO (MICROSOME) TEST	Jan 03, 1991	Substantially Equivalent	General Biometrics, Inc.
K903843	IMMUNODOT THYROID AUTOIMMUNITY PANEL	Oct 02, 1990	Substantially Equivalent	General Biometrics, Inc.