JZO · Class II · 21 CFR 866.5870

FDA Product Code JZO: System, Test, Thyroid Autoantibody

FDA product code JZO covers thyroid autoantibody test systems used in the diagnosis of autoimmune thyroid diseases.

These immunoassays detect antibodies against thyroid peroxidase (TPO), thyroglobulin, or TSH receptors in serum, enabling the diagnosis of Hashimoto's thyroiditis, Graves' disease, and other autoimmune thyroid conditions.

JZO devices are Class II medical devices, regulated under 21 CFR 866.5870 and reviewed by the FDA Immunology panel.

Leading manufacturers include Roche Diagnostics Corp., Diagnostic Products Corp. and Beckman Coulter, Inc..

92
Total
92
Cleared
104d
Avg days
1976
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 217d recently vs 102d historically

FDA 510(k) Cleared System, Test, Thyroid Autoantibody Devices (Product Code JZO)

92 devices
1–24 of 92
Cleared Oct 17, 2025
ADVIA Centaur Anti-Thyroid Peroxidase II
K250250
Siemens Healthcare Diagnostics, Inc.
Immunology · 262d
Cleared Aug 09, 2024
Access TPO Antibody
K240469
Beckman Coulter, Inc.
Immunology · 171d
Cleared Sep 26, 2023
Access Thyroglobulin Antibody II
K213517
Beckman Coulter, Inc.
Immunology · 692d
Cleared Sep 15, 2023
Elecsys Anti-Tg
K222610
Roche Diagnostics
Immunology · 382d
Cleared Feb 27, 2020
Elecsys Anti-TSHR
K193313
Roche Diagnostics
Immunology · 90d
Cleared Jul 28, 2008
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092
Roche Diagnostics Corp.
Immunology · 196d
Cleared Jul 06, 2006
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
K061382
Beckman Coulter, Inc.
Immunology · 49d
Cleared Feb 07, 2006
ROCHE ELECSYS ANTI-TG
K053426
Roche Diagnostics Corp.
Immunology · 61d
Cleared Aug 04, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
K051890
Roche Diagnostics Corp.
Immunology · 23d
Cleared Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
K020672
Roche Diagnostics Corp.
Immunology · 157d
Cleared May 17, 2000
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
K000155
Roche Diagnostics Corp.
Immunology · 119d
Cleared May 13, 1999
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
K991094
Diagnostic Products Corp.
Immunology · 42d
Cleared May 13, 1999
IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
K991096
Diagnostic Products Corp.
Immunology · 42d
Cleared May 01, 1998
IMMULITE ANTI-TG AB
K980206
Diagnostic Products Corp.
Immunology · 101d
Cleared Jan 17, 1997
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ
K963695
Diagnostic Products Corp.
Immunology · 123d
Cleared Jun 09, 1982
CORDIA TG
K821489
Cordis Corp.
Chemistry · 22d

About Product Code JZO - Regulatory Context

510(k) Submission Activity

92 total 510(k) submissions under product code JZO since 1976, with 92 receiving FDA clearance (average review time: 104 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - JZO Product Code

Recent submissions under JZO have taken an average of 217 days to reach a decision - up from 102 days historically. Manufacturers should account for longer review timelines in current project planning.

JZO devices are reviewed by the Immunology panel. Browse all Immunology devices →