JNL · Class II · 21 CFR 866.5870

FDA Product Code JNL: Immunochemical, Thyroglobulin Autoantibody

Leading manufacturers include Beckman Coulter, Inc., Cogent Diagnotics , Ltd. and Organon Teknika Corp..

22
Total
22
Cleared
111d
Avg days
1990
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 261d recently vs 104d historically

FDA 510(k) Cleared Immunochemical, Thyroglobulin Autoantibody Devices (Product Code JNL)

22 devices
1–22 of 22
Cleared Dec 04, 2025
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
K250816
Siemens Healthcare Diagnostics, Inc.
Immunology · 261d
Cleared Jul 03, 2024
Access Thyroglobulin Antibody II
K240996
Beckman Coulter, Inc.
Immunology · 83d
Cleared Dec 27, 2011
ACCESS THYROGLOBULIN ANITBODY
K112933
Beckman Coulter, Inc.
Immunology · 85d
Cleared Nov 20, 2007
IMMUNOCAP THYRLOBULIN IMMUNOCAP
K072661
Phadia US, Inc.
Immunology · 60d
Cleared Oct 05, 2006
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
K062516
Beckman Coulter, Inc.
Immunology · 38d
Cleared Jul 03, 1997
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
K971834
Monobind
Immunology · 45d
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
K962341
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
K962451
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Aug 25, 1995
AURAFLEX TG-AB AND TPO-AB
K951320
Organon Teknika Corp.
Immunology · 155d
Cleared Aug 25, 1995
AURAFLEX TPO-AB
K952607
Organon Teknika Corp.
Immunology · 86d
Cleared Apr 17, 1995
AUTOSTAT II ANTI-TPO
K943580
Cogent Diagnotics , Ltd.
Immunology · 269d
Cleared Sep 22, 1992
AUTOSTAT ANTI-THYROGLOBULIN
K923370
Cogent Diagnotics , Ltd.
Immunology · 75d
Cleared Sep 22, 1992
AUTOSTAT ANTI-THYROID MICROSSOMAL
K923371
Cogent Diagnotics , Ltd.
Immunology · 75d
Cleared Jul 28, 1992
SYNELISA TPO ANTIBODIES
K921787
Elias U.S.A., Inc.
Immunology · 105d
Cleared Jan 03, 1991
IMMUNOWELL TPO (MICROSOME) TEST
K905486
General Biometrics, Inc.
Immunology · 28d
Cleared Oct 02, 1990
IMMUNODOT THYROID AUTOIMMUNITY PANEL
K903843
General Biometrics, Inc.
Chemistry · 42d

About Product Code JNL - Regulatory Context

510(k) Submission Activity

22 total 510(k) submissions under product code JNL since 1990, with 22 receiving FDA clearance (average review time: 111 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - JNL Product Code

Recent submissions under JNL have taken an average of 261 days to reach a decision - up from 104 days historically. Manufacturers should account for longer review timelines in current project planning.

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