FDA Product Code CDZ: Radioimmunoassay, Testosterones And Dihydrotestosterone
FDA product code CDZ covers radioimmunoassay systems for the measurement of testosterone and dihydrotestosterone in serum.
These assays quantify androgens involved in male sexual development, reproductive function, and secondary sex characteristics. Testosterone measurement is used in the diagnosis of hypogonadism, polycystic ovary syndrome, and monitoring of androgen replacement therapy.
CDZ devices are Class I medical devices, regulated under 21 CFR 862.1680 and reviewed by the FDA Immunology panel.
Leading manufacturers include Diagnostic Products Corp., Beckman Coulter, Inc. and Abbott Laboratories.
89
Total
89
Cleared
109d
Avg days
1978
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg
220d
recently vs 106d historically
FDA 510(k) Cleared Radioimmunoassay, Testosterones And Dihydrotestosterone Devices (Product Code CDZ)
89 devices
Cleared
Apr 15, 2026
IDS-iSYS Total Testosterone
Immunodiagnostic Systems Limited
Chemistry
230d
Cleared
Oct 23, 2024
IDS-iSYS Free Testosterone
Immunodiagnostic Systems Limited
Chemistry
209d
Cleared
Feb 08, 2024
Access SHBG
Beckman Coulter, Inc.
Chemistry
105d
Cleared
Jan 13, 2023
Access Testosterone
Beckman Coulter, Inc.
Chemistry
65d
Cleared
May 06, 2022
Elecsys Testosterone II
Roche Diagnostics
Chemistry
338d
Cleared
Oct 15, 2020
LIAISON Testosterone xt
DiaSorin, Inc.
Chemistry
98d
Cleared
Dec 20, 2019
ACTIVE® Free Testosterone RIA
Immunotech S.R.O.
Chemistry
214d
Cleared
Aug 28, 2019
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
Siemens Healthcare Diagnostics, Inc.
Chemistry
79d
Cleared
Jun 17, 2019
IDS SHBG
Immunodiagnostic Systems , Ltd.
Chemistry
143d
Cleared
Jan 29, 2019
FastPack IP Sex Hormone Binding Globulin Immunoassay
Qualigen, Inc.
Chemistry
138d
Cleared
Jul 20, 2018
Free Testosterone AccuBind ELISA Test System
Monobind, Inc.
Chemistry
101d
Cleared
Dec 17, 2015
ARCHITECT 2nd Generation Testosterone
Abbott Laboratories
Chemistry
136d
Cleared
Sep 11, 2012
TESTOSTERONE TEST SYSTEM
Abbott Laboratories
Chemistry
252d
Cleared
Apr 23, 2010
ELECSYS TESTOSTERONE II IMMUNOASSAY
Roche Diagnostics Corp.
Chemistry
171d
Cleared
Aug 27, 2009
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
Beckman Coulter, Inc.
Chemistry
241d
Cleared
Oct 10, 2003
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
Diagnostic Products Corp.
Chemistry
25d
Cleared
Aug 05, 2003
ELECSYS SHBG IMMUNOASSAY
Roche Diagnostics Corp.
Chemistry
63d
Cleared
Jul 18, 2002
VIDAS TESTOSTERONE (TES), MODEL 30 418
bioMerieux, Inc.
Chemistry
83d
Cleared
Aug 22, 2000
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
Beckman Coulter, Inc.
Chemistry
57d
Cleared
Nov 18, 1998
ABBOTT ARCHITECT TESTOSTERONE
Abbott Laboratories
Chemistry
65d
Cleared
Mar 18, 1997
ELECSYS TESTOSTERONE ASSAY
Boehringer Mannheim Corp.
Chemistry
102d
Cleared
Feb 06, 1996
IMMULITE TOTAL TESTOSTERONE
Diagnostic Products Corp.
Chemistry
40d
Cleared
Dec 21, 1995
IMMULITE SHBG (MODIFICATION)
Diagnostic Products Corp.
Chemistry
59d
Cleared
Oct 31, 1994
IMMULITE SHBG
Diagnostic Products Corp.
Chemistry
202d
About Product Code CDZ - Regulatory Context
510(k) Submission Activity
89 total 510(k) submissions under product code CDZ since 1978, with 89 receiving FDA clearance (average review time: 109 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - CDZ Product Code
Recent submissions under CDZ have taken an average of 220 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.
CDZ devices are reviewed by the Chemistry panel. Browse all Chemistry devices →