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 American Laboratory Products Co., Ltd., Roche Diagnostics Corp. and Elias U.S.A., Inc..

92
Total
92
Cleared
104d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 262d recently vs 103d 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 Mar 25, 2016
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
K151799
Phadia AB
Immunology · 267d
Cleared Mar 03, 2016
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
K152061
Siemens Healthcare Diagnostics, Inc.
Immunology · 223d
Cleared May 18, 2010
THYRETAIN TM TSI REPORTER BIOASSAY
K092229
Diagnostic Hybrids, Inc.
Immunology · 299d
Cleared Sep 03, 2009
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
K090760
Theratest Laboratories, Inc.
Immunology · 164d
Cleared May 21, 2009
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
K083391
Diagnostic Hybrids, Inc.
Immunology · 185d
Cleared Jul 28, 2008
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092
Roche Diagnostics Corp.
Immunology · 196d
Cleared Jul 18, 2006
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
K052407
Fisher Diagnostics
Immunology · 320d
Cleared Jul 06, 2006
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
K061382
Beckman Coulter, Inc.
Immunology · 49d
Cleared May 10, 2006
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
K052308
Fisher Diagnostics
Immunology · 259d
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 Mar 22, 2004
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
K033977
Zeus Scientific, Inc.
Immunology · 90d
Cleared Feb 06, 2003
SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
K023593
Quest Intl., Inc.
Immunology · 104d
Cleared Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
K020672
Roche Diagnostics Corp.
Immunology · 157d
Cleared May 02, 2002
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS
K020348
Axis-Shield Diagnostics, Ltd.
Immunology · 87d
Cleared May 02, 2002
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
K020349
Axis-Shield Diagnostics, Ltd.
Immunology · 87d
Cleared May 02, 2002
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
K020687
Axis-Shield Diagnostics, Ltd.
Immunology · 59d
Cleared Oct 22, 2001
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
K012777
Bayer Corp.
Immunology · 63d
Cleared May 30, 2001
ALPCO MILENIA ANTI-TG EIA
K011415
American Laboratory Products Co., Ltd.
Immunology · 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 declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - JZO Product Code

Recent submissions under JZO have taken an average of 262 days to reach a decision - up from 103 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 →