Radioimmunoassay, Testosterones And Dihydrotestosterone
FDA product code CDZ · Class I (low risk) · 21 CFR 862.1680 · Clinical Chemistry
89510(k) clearances
0PMA approvals
17recalls
Manufacturers
- Diagnostic Products Corp. 9
- Diagnostic Systems Laboratories, Inc. 7
- Siemens Healthcare Diagnostics, Inc. 5
- Beckman Coulter Inc. 4
- Roche Diagnostics Corp. 4
- Leeco Diagnostics, Inc. 4
- Immunodiagnostic Systems , Ltd. 3
- Abbott Laboratories 3
- Qualigen, Inc. 3
- Wallac OY 2
- Serono-Baker Diagnostics, Inc. 2
- Drg Intl., Inc. 2
- Pantex, Div. Bio-Analysis, Inc. 2
- Cambridge Medical Technology 2
- Wien Laboratories, Inc. 2
- DiaSorin, Inc. 2
- Diagnostics Biochem Canada, Inc. 2
- Immuchem Corp. 2
- Sorin Biomedica, Fiat, USA, Inc. 2
- Biokit, S.A. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252728 | IDS-iSYS Total TestosteroneCDZ · Traditional | Immunodiagnostic Systems Limited | 04/15/2026SE |
| K240865 | IDS-iSYS Free TestosteroneCDZ · Traditional | Immunodiagnostic Systems Limited | 10/23/2024SE |
| K233480 | Access SHBGCDZ · Traditional | Beckman Coulter, Inc. | 02/08/2024SE |
| K223405 | Access TestosteroneCDZ · Traditional | Beckman Coulter, Inc. | 01/13/2023SE |
| K211685 | Elecsys Testosterone IICDZ · Traditional | Roche Diagnostics | 05/06/2022SE |
| K201908 | LIAISON Testosterone xtCDZ · Special | DiaSorin, Inc. | 10/15/2020SE |
| K191350 | ACTIVE® Free Testosterone RIACDZ · Special | Immunotech S.R.O. | 12/20/2019SE |
| K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGCDZ · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/28/2019SE |
| K190121 | Ids SHBGCDZ · Traditional | Immunodiagnostic Systems , Ltd. | 06/17/2019SE |
| K182521 | FastPack IP Sex Hormone Binding Globulin ImmunoassayCDZ · Traditional | Qualigen, Inc. | 01/29/2019SE |
| K181017 | Free Testosterone AccuBind ELISA Test SystemCDZ · Traditional | Monobind, Inc. | 07/20/2018SE |
| K153577 | FREND Testosterone Test SystemCDZ · Traditional | Nanoentek USA, Inc. | 10/14/2016SE |
| K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…CDZ · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/29/2016SE |
| K152185 | Architect SHBGCDZ · Traditional | Biokit, S.A. | 02/11/2016SE |
| K151529 | Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista…CDZ · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/11/2016SE |
| K152155 | ARCHITECT 2nd Generation TestosteroneCDZ · Traditional | Abbott Laboratories | 12/17/2015SE |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetCDZ · Traditional | Tosoh Bioscience, Inc. | 07/02/2015SE |
| K133491 | Advia Centaur Testosterone (Tsto)CDZ · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/21/2014SE |
| K122793 | Liaison Testosterone; Liaison Testosterone Control SetCDZ · Traditional | DiaSorin, Inc. | 01/25/2013SE |
| K120009 | Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed)CDZ · Traditional | Abbott Laboratories | 09/11/2012SE |
| K101388 | Fastpack Testo ImmunoassayCDZ · Special | Qualigen, Inc. | 02/18/2011SE |
| K102814 | Elecysys SHBGCDZ · Traditional | Roche Diagnostics | 01/20/2011SE |
| K093421 | Elecsys Testosterone II ImmunoassayCDZ · Traditional | Roche Diagnostics Corp. | 04/23/2010SE |
| K091867 | Advia Centaur SHBG Readypack, Low and High Calibrators and Master Curve Material, Models…CDZ · Traditional | Siemens Healthcare Diagnostics | 01/14/2010SE |
| K083867 | Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin…CDZ · Traditional | Beckman Coulter, Inc. | 08/27/2009SE |
| K060818 | Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control…CDZ · Traditional | Biokit, S.A. | 01/23/2007SE |
| K052649 | DRG SLV Testosterone Elisa TestCDZ · Traditional | Drg Intl., Inc. | 01/27/2006SE |
| K041866 | Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia)CDZ · Traditional | Axis-Shield Diagnostics, Ltd. | 09/29/2004SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | Diagnostic Products Corp. | 10/10/2003SE |
| K030730 | Free Testosterone Enzymeimmunoassay (Eia) KitCDZ · Traditional | Diagnostics Biochem Canada, Inc. | 08/18/2003SE |
| K031717 | Elecsys SHBG ImmunoassayCDZ · Traditional | Roche Diagnostics Corp. | 08/05/2003SE |
| K023091 | ST Aia-Pack Testosterone AssayCDZ · Traditional | Tosoh Medics, Inc. | 12/17/2002SE |
| K021972 | Fastpack Total Testosterone ImmunoassayCDZ · Traditional | Qualigen, Inc. | 08/21/2002SE |
| K021326 | Vidas Testosterone (Tes), Model 30 418CDZ · Traditional | bioMerieux, Inc. | 07/18/2002SE |
| K014120 | Testosterone by Enzymeimmunoassay (Eia)CDZ · Traditional | Diagnostics Biochem Canada, Inc. | 02/08/2002SE |
| K002294 | Biocheck Testosterone Eia, Model BC-1115CDZ · Traditional | Biocheck, Inc. | 10/02/2000SE |
| K001935 | Access Testosterone Reagents for Use on the Access Immunoassay Analyzer, Models 33560…CDZ · Traditional | Beckman Coulter, Inc. | 08/22/2000SE |
| K001086 | Free Testosterone Enzyme Immunoassay, Model DSL-10-4900CDZ · Traditional | Diagnostic Systems Laboratories, Inc. | 05/18/2000SE |
| K000043 | DRG Aurica Elisa Testosterone KitCDZ · Traditional | Drg Intl., Inc. | 04/17/2000SE |
| K983212 | Abbott Architect TestosteroneCDZ · Traditional | Abbott Laboratories | 11/18/1998SE |
| K973900 | Testoterone ElisaCDZ · Traditional | Kmi Diagnostics, Inc. | 02/24/1998SE |
| K971823 | Active Testosterone Eia (DSL-10-4000)CDZ · Traditional | Diagnostic Systems Laboratories, Inc. | 06/16/1997SE |
| K964889 | Elecsys Testosterone AssayCDZ · Traditional | Boehringer Mannheim Corp. | 03/18/1997SE |
| K963080 | Testosteronee Assay for the Technicon Immuno 1 System (In-Vitro Diagnostic System)CDZ · Traditional | Bayer Corp. | 09/27/1996SE |
| K955102 | Biodata Testosterone Maia KitCDZ · Traditional | Biochem Immunosystems (U.S.), Inc. | 06/24/1996SE |
| K955870 | Immulite Total TestosteroneCDZ · Traditional | Diagnostic Products Corp. | 02/06/1996SE |
| K955440 | Immulite SHBG (Modification)CDZ · Traditional | Diagnostic Products Corp. | 12/21/1995SE |
| K951685 | Auraflex Testosterone Calibrator PackCDZ · Traditional | Organon Teknika Corp. | 11/14/1995SE |
| K952281 | Active Free Testosterone RiaCDZ · Traditional | Diagnostic Systems Laboratories, Inc. | 07/17/1995SE |
| K941797 | Immulite SHBGCDZ · Traditional | Diagnostic Products Corp. | 10/31/1994SE |
| K940449 | Delfia SHBG KitCDZ · Traditional | Wallac OY | 09/06/1994SE |
| K934562 | Ciba Corning Acs Testosterone ImmunoassayCDZ · Traditional | Ciba Corning Diagnostics Corp. | 12/10/1993SE |
| K932951 | Delfia Testtosterone KitCDZ · Traditional | Wallac OY | 08/03/1993SE |
| K924257 | Testosterone Serozyme(Tm) Enzyme ImmunoassayCDZ · Traditional | Serono-Baker Diagnostics, Inc. | 11/30/1992SE |
| K915823 | DSL Active SHBG (DSL 7400)CDZ · Traditional | Diagnostic Systems Laboratories, Inc. | 03/17/1992SE |
| K915164 | Sri Testosterone Enzyme ImmunoassayCDZ · Traditional | Serono-Baker Diagnostics, Inc. | 03/02/1992SE |
| K915570 | Gamma Coat Assay Testosterone Radioimmunoassay KitCDZ · Traditional | Incstar Corp. | 01/27/1992SE |
| K912850 | SHBGCDZ · Traditional | Wien Laboratories, Inc. | 08/12/1991SE |
| K905247 | SHBG Irma KitCDZ · Traditional | Ventrex Laboratories, Inc. | 01/17/1991SE |
| K904100 | DSL Sex Hormone Binding Globulin (SHBG) (DSL 6300)CDZ · Traditional | Diagnostic Systems Laboratories, Inc. | 10/15/1990SE |
| K884809 | Delfia SHBG KitCDZ · Traditional | Pharmacia, Inc. | 03/08/1989SE |
| K883267 | Irma-Count (TM) SHBG (Sex Hormorne Bind Globulin)CDZ · Traditional | Diagnostic Products Corp. | 10/31/1988SE |
| K861679 | SHBG Irma KitCDZ · Traditional | Farmos Group , Ltd. | 03/13/1987SE |
| K862483 | Pantex Fte Free Testosterone Radioimmunoassay KitCDZ · Traditional | Pantex, Div. Bio-Analysis, Inc. | 01/14/1987SE |
| K860003 | Leeco Testosterone Diagnostic KitCDZ · Traditional | Leeco Diagnostics, Inc. | 03/17/1986SE |
| K860130 | Testosterone Coated Tubes Radioimmunoassay KitCDZ · Traditional | Cambridge Medical Technology | 02/19/1986SE |
| K854674 | DSL Androstendione Ria (DSL #4200)CDZ · Traditional | Diagnostic Systems Laboratories, Inc. | 12/19/1985SE |
| K854671 | DSL Active Testosterone Ria (DSL #4000)CDZ · Traditional | Diagnostic Systems Laboratories, Inc. | 12/19/1985SE |
| K853865 | Pantex Direct Testosterone Coated Tube RadioimmunoCDZ · Traditional | Pantex, Div. Bio-Analysis, Inc. | 10/15/1985SE |
| K844423 | Coat-A-Count Free Testosterone Kit & ComponentsCDZ · Traditional | Diagnostic Products Corp. | 02/27/1985SE |
| K841948 | Testosterone Direct RadioimmunoassayCDZ · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 06/25/1984SE |
| K841042 | Matched Component Set RadioimmunoassayCDZ · Traditional | Cambridge Medical Technology | 04/19/1984SE |
| K840187 | Immophase Dtesto Radioimmunoassay-CDZ · Traditional | Corning Medical & Scientific | 03/23/1984SE |
| K831342 | Coat-A-Count No-Extraction TestosteroneCDZ · Traditional | Diagnostic Products Corp. | 06/02/1983SE |
| K830512 | Leeco Testosterone Diagnostic KitCDZ · Traditional | Leeco Diagnostics, Inc. | 04/05/1983SE |
| K813401 | Coat-A-Count Testosterone Ria KitCDZ · Traditional | Diagnostic Products Corp. | 12/22/1981SE |
| K813059 | Leeco Testo-Quant Diag. KitCDZ · Traditional | Leeco Diagnostics, Inc. | 11/16/1981SE |
| K811536 | Direct Testosterone RiaCDZ · Traditional | Immuchem Corp. | 06/18/1981SE |
| K803001 | Leeco Testo-Quant Diagnostic KitCDZ · Traditional | Leeco Diagnostics, Inc. | 01/02/1981SE |
| K802728 | 125I-TESTOSTERONE Test SetCDZ · Traditional | Wien Laboratories, Inc. | 12/11/1980SE |
| K802661 | Liquisol Testosterone Radioimm. Test KitCDZ · Traditional | Damon Corp. | 12/10/1980SE |
| K802135 | Testosterone Radioimmunoassy KitCDZ · Traditional | Radioimmunoassay, Inc. | 10/10/1980SE |
| K801666 | Testosterone KitCDZ · Traditional | Immuchem Corp. | 08/27/1980SE |
| K800921 | Nordiclab Testosterone Ria TestCDZ · Traditional | Nordiclab Intl. | 05/14/1980SE |
| K800776 | TESTOK-125CDZ · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 04/21/1980SE |
| K791999 | (125I) Testosterone KitCDZ · Traditional | Radioassay Systems Laboratories, Inc. | 10/30/1979SE |
| K790007 | I TestoteroneCDZ · Traditional | Cambridge Nuclear Corp. | 02/26/1979SE |
| K780792 | Testosterone Radioimmunoassay Kit 125ICDZ · Traditional | The Upjohn Co. | 06/13/1978SE |
| K772191 | Testosterone Ria Kit (125I)CDZ · Traditional | Diagnostic Products Corp. | 01/12/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2746-2026 Class II | ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement…The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the… | Tosoh Bioscience Inc | 06/12/2026Open, Classified |
| Z-0788-2026 Class II | Men s Hormone TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-1901-2025 Class II | Access Testosterone assay, Catalog Number 33560Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing… | Beckman Coulter, Inc. | 05/05/2025Open, Classified |
| Z-0805-2025 Class III | The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the…Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect… | Qualigen Inc | 12/03/2024Open, Classified |
| Z-2622-2024 Class III | Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product…Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in… | DRG International, Inc. | 07/05/2024Open, Classified |
| Z-0355-2023 Class II | IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the…Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9… | Siemens Healthcare Diagnostics, Inc. | 10/25/2022Open, Classified |
| Z-1672-2020 Class II | The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement…The chemiluminescent immunoassay has been noted to have higher than expected results which may result in… | Qualigen Inc | 11/06/2019Terminated |
| Z-2159-2019 Class II | DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva…Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too… | DRG Instruments GmbH | 05/21/2019Terminated |
| Z-0674-2019 Class II | ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the… | Tosoh Bioscience Inc | 11/30/2018Terminated |
| Z-2438-2018 Class II | Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective… | Siemens Healthcare Diagnostics, Inc. | 03/21/2018Terminated |
| Z-2093-2018 Class II | ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-2092-2018 Class II | ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-2339-2017 Class II | VIDAS Testosterone, Ref 30418Complaints were received from customers observing falsely overestimate results or external quality control… | bioMerieux, Inc. | 05/15/2017Terminated |
| Z-2613-2017 Class II | ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle…Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may… | Abbott Laboratories | 04/18/2017Terminated |
| Z-2166-2017 Class II | SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE…Certain lots of Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adjustor… | Siemens Healthcare Diagnostics, Inc. | 01/31/2017Terminated |
| Z-0548-2014 Class II | FastPack Testosterone Immunoassay Chemilunescence assay for the determination of…Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a… | Qualigen Inc | 11/08/2013Terminated |
| Z-0431-2011 | Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part…The recall was initiated because the Instruction for Use (IFU) for Access SHBG does not specify the units of… | Beckman Coulter Inc. | 07/26/2010Terminated |