Product Code: CDZ
FDA class 1
21 CFR 862.1680
Radioimmunoassay, Testosterones And Dihydrotestosterone
Clinical Chemistry
The Testosterones and Dihydrotestosterone Radioimmunoassay is a clinical chemistry device that uses radiolabeled immunoassay techniques to measure testosterone and dihydrotestosterone (DHT) concentrations in blood, used in the evaluation of androgen excess or deficiency, hypogonadism, and related endocrine disorders. It is classified as FDA Class 1 (lowest risk). The product code is CDZ, regulated under 21 CFR 862.1680, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.
510(k)s
88
FEI Numbers
60
Registration Numbers
60
Unique Applicants
55
Years Active
47
Basic Information
- Product Code
- CDZ
- Device Class
- FDA class 1
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 88 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240865 | IDS-iSYS Free Testosterone | Oct 23, 2024 | Substantially Equivalent | Immunodiagnostic Systems Limited |
| K233480 | Access SHBG | Feb 08, 2024 | Substantially Equivalent | Beckman Coulter Inc. |
| K223405 | Access Testosterone | Jan 13, 2023 | Substantially Equivalent | Beckman Coulter, Inc. |
| K211685 | Elecsys Testosterone II | May 06, 2022 | Substantially Equivalent | Roche Diagnostics |
| K201908 | LIAISON Testosterone xt | Oct 15, 2020 | Substantially Equivalent | DiaSorin Inc. |
| K191350 | ACTIVE® Free Testosterone RIA | Dec 20, 2019 | Substantially Equivalent | Immunotech s.r.o. |
| K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Aug 28, 2019 | Substantially Equivalent | Siemens Healthcare Diagnostics Inc. |
| K190121 | IDS SHBG | Jun 17, 2019 | Substantially Equivalent | Immunodiagnostic Systems Ltd. |
| K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | Jan 29, 2019 | Substantially Equivalent | Qualigen, Inc. |
| K181017 | Free Testosterone AccuBind ELISA Test System | Jul 20, 2018 | Substantially Equivalent | Monobind Inc. |
| K153577 | FREND Testosterone Test System | Oct 14, 2016 | Substantially Equivalent | NanoEnTek USA Inc. |
| K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material | Jun 29, 2016 | Substantially Equivalent | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| K152185 | ARCHITECT SHBG | Feb 11, 2016 | Substantially Equivalent | BIOKIT, S.A. |
| K151529 | Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator | Feb 11, 2016 | Substantially Equivalent | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K152155 | ARCHITECT 2nd Generation Testosterone | Dec 17, 2015 | Substantially Equivalent | Abbott Laboratories |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | Jul 02, 2015 | Substantially Equivalent | TOSOH BIOSCIENCE, INC. |
| K133491 | ADVIA CENTAUR TESTOSTERONE (TSTO) | Feb 21, 2014 | Substantially Equivalent | Siemens Healthcare Diagnostics Inc. |
| K122793 | LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET | Jan 25, 2013 | Substantially Equivalent | DIASORIN, INC. |
| K120009 | TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) | Sep 11, 2012 | Substantially Equivalent | ABBOTT LABORATORIES |
| K101388 | FASTPACK TESTO IMMUNOASSAY | Feb 18, 2011 | Substantially Equivalent | Qualigen, Inc. |
| K102814 | ELECYSYS SHBG | Jan 20, 2011 | Substantially Equivalent | Roche Diagnostics |
| K093421 | ELECSYS TESTOSTERONE II IMMUNOASSAY | Apr 23, 2010 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K091867 | ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 | Jan 14, 2010 | Substantially Equivalent | SIEMENS HEALTHCARE DIAGNOSTICS |
| K083867 | ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND | Aug 27, 2009 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K060818 | ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 | Jan 23, 2007 | Substantially Equivalent | BIOKIT S.A. |
| K052649 | DRG SLV TESTOSTERONE ELISA TEST | Jan 27, 2006 | Substantially Equivalent | DRG INTL., INC. |
| K041866 | ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) | Sep 29, 2004 | Substantially Equivalent | AXIS-SHIELD DIAGNOSTICS, LTD. |
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE | Oct 10, 2003 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K030730 | FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT | Aug 18, 2003 | Substantially Equivalent | DIAGNOSTICS BIOCHEM CANADA, INC. |
| K031717 | ELECSYS SHBG IMMUNOASSAY | Aug 05, 2003 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K023091 | ST AIA-PACK TESTOSTERONE ASSAY | Dec 17, 2002 | Substantially Equivalent | TOSOH MEDICS, INC. |
| K021972 | FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY | Aug 21, 2002 | Substantially Equivalent | Qualigen, Inc. |
| K021326 | VIDAS TESTOSTERONE (TES), MODEL 30 418 | Jul 18, 2002 | Substantially Equivalent | BIOMERIEUX, INC. |
| K014120 | TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) | Feb 08, 2002 | Substantially Equivalent | DIAGNOSTICS BIOCHEM CANADA, INC. |
| K002294 | BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 | Oct 02, 2000 | Substantially Equivalent | BIOCHECK, INC. |
| K001935 | ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 | Aug 22, 2000 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K001086 | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 | May 18, 2000 | Substantially Equivalent | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K000043 | DRG AURICA ELISA TESTOSTERONE KIT | Apr 17, 2000 | Substantially Equivalent | DRG INTL., INC. |
| K983212 | ABBOTT ARCHITECT TESTOSTERONE | Nov 18, 1998 | Substantially Equivalent | ABBOTT LABORATORIES |
| K973900 | TESTOTERONE ELISA | Feb 24, 1998 | Substantially Equivalent | KMI DIAGNOSTICS, INC. |
| K971823 | ACTIVE TESTOSTERONE EIA (DSL-10-4000) | Jun 16, 1997 | Substantially Equivalent | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K964889 | ELECSYS TESTOSTERONE ASSAY | Mar 18, 1997 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K963080 | TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) | Sep 27, 1996 | Substantially Equivalent | BAYER CORP. |
| K955102 | BIODATA TESTOSTERONE MAIA KIT | Jun 24, 1996 | Substantially Equivalent | BIOCHEM IMMUNOSYSTEMS (U.S.), INC. |
| K955870 | IMMULITE TOTAL TESTOSTERONE | Feb 06, 1996 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K955440 | IMMULITE SHBG (MODIFICATION) | Dec 21, 1995 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K951685 | AURAFLEX TESTOSTERONE CALIBRATOR PACK | Nov 14, 1995 | Substantially Equivalent | ORGANON TEKNIKA CORP. |
| K952281 | ACTIVE FREE TESTOSTERONE RIA | Jul 17, 1995 | Substantially Equivalent | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K941797 | IMMULITE SHBG | Oct 31, 1994 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K940449 | DELFIA SHBG KIT | Sep 06, 1994 | Substantially Equivalent | WALLAC OY |
| K934562 | CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY | Dec 10, 1993 | Substantially Equivalent | CIBA CORNING DIAGNOSTICS CORP. |
| K932951 | DELFIA TESTTOSTERONE KIT | Aug 03, 1993 | Substantially Equivalent | WALLAC OY |
| K924257 | TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY | Nov 30, 1992 | Substantially Equivalent | SERONO-BAKER DIAGNOSTICS, INC. |
| K915823 | DSL ACTIVE SHBG (DSL 7400) | Mar 17, 1992 | Substantially Equivalent | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K915164 | SRI TESTOSTERONE ENZYME IMMUNOASSAY | Mar 02, 1992 | Substantially Equivalent | SERONO-BAKER DIAGNOSTICS, INC. |
| K915570 | GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT | Jan 27, 1992 | Substantially Equivalent | INCSTAR CORP. |
| K912850 | SHBG | Aug 12, 1991 | Substantially Equivalent | WIEN LABORATORIES, INC. |
| K905247 | SHBG IRMA KIT | Jan 17, 1991 | Substantially Equivalent | VENTREX LABORATORIES, INC. |
| K904100 | DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300) | Oct 15, 1990 | Substantially Equivalent | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K884809 | DELFIA SHBG KIT | Mar 08, 1989 | Substantially Equivalent | PHARMACIA, INC. |
| K883267 | IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) | Oct 31, 1988 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K861679 | SHBG IRMA KIT | Mar 13, 1987 | Substantially Equivalent | FARMOS GROUP LTD. |
| K862483 | PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT | Jan 14, 1987 | Substantially Equivalent | PANTEX, DIV. BIO-ANALYSIS, INC. |
| K860003 | LEECO TESTOSTERONE DIAGNOSTIC KIT | Mar 17, 1986 | Substantially Equivalent | LEECO DIAGNOSTICS, INC. |
| K860130 | TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT | Feb 19, 1986 | Substantially Equivalent | CAMBRIDGE MEDICAL TECHNOLOGY |
| K854674 | DSL ANDROSTENDIONE RIA (DSL #4200) | Dec 19, 1985 | Substantially Equivalent | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K854671 | DSL ACTIVE TESTOSTERONE RIA (DSL #4000) | Dec 19, 1985 | Substantially Equivalent | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K853865 | PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO | Oct 15, 1985 | Substantially Equivalent | PANTEX, DIV. BIO-ANALYSIS, INC. |
| K844423 | COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS | Feb 27, 1985 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K841948 | TESTOSTERONE DIRECT RADIOIMMUNOASSAY | Jun 25, 1984 | Substantially Equivalent | SORIN BIOMEDICA, FIAT, USA, INC. |
| K841042 | MATCHED COMPONENT SET RADIOIMMUNOASSAY | Apr 19, 1984 | Substantially Equivalent | CAMBRIDGE MEDICAL TECHNOLOGY |
| K840187 | IMMOPHASE DTESTO RADIOIMMUNOASSAY- | Mar 23, 1984 | Substantially Equivalent | CORNING MEDICAL & SCIENTIFIC |
| K831342 | COAT-A-COUNT NO-EXTRACTION TESTOSTERONE | Jun 02, 1983 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K830512 | LEECO TESTOSTERONE DIAGNOSTIC KIT | Apr 05, 1983 | Substantially Equivalent | LEECO DIAGNOSTICS, INC. |
| K813401 | COAT-A-COUNT TESTOSTERONE RIA KIT | Dec 22, 1981 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K813059 | LEECO TESTO-QUANT DIAG. KIT | Nov 16, 1981 | Substantially Equivalent | LEECO DIAGNOSTICS, INC. |
| K811536 | DIRECT TESTOSTERONE RIA | Jun 18, 1981 | Substantially Equivalent | IMMUCHEM CORP. |
| K803001 | LEECO TESTO-QUANT DIAGNOSTIC KIT | Jan 02, 1981 | Substantially Equivalent | LEECO DIAGNOSTICS, INC. |
| K802728 | 125I-TESTOSTERONE TEST SET | Dec 11, 1980 | Substantially Equivalent | WIEN LABORATORIES, INC. |
| K802661 | LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT | Dec 10, 1980 | Substantially Equivalent | DAMON CORP. |
| K802135 | TESTOSTERONE RADIOIMMUNOASSY KIT | Oct 10, 1980 | Substantially Equivalent | RADIOIMMUNOASSAY, INC. |
| K801666 | TESTOSTERONE KIT | Aug 27, 1980 | Substantially Equivalent | IMMUCHEM CORP. |
| K800921 | NORDICLAB TESTOSTERONE RIA TEST | May 14, 1980 | Substantially Equivalent | NORDICLAB INTL. |
| K800776 | TESTOK-125 | Apr 21, 1980 | Substantially Equivalent | SORIN BIOMEDICA, FIAT, USA, INC. |
| K791999 | (125I) TESTOSTERONE KIT | Oct 30, 1979 | Substantially Equivalent | RADIOASSAY SYSTEMS LABORATORIES, INC. |
| K790007 | I TESTOTERONE | Feb 26, 1979 | Substantially Equivalent | CAMBRIDGE NUCLEAR CORP. |
| K780792 | TESTOSTERONE RADIOIMMUNOASSAY KIT 125I | Jun 13, 1978 | Substantially Equivalent | THE UPJOHN CO. |
| K772191 | TESTOSTERONE RIA KIT (125I) | Jan 12, 1978 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
FEI Numbers
This FDA classification entry is associated with 60 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.