CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone
Clinical Chemistry · 21 CFR 862.1680 · Class 1
Overview
| Product Code | CDZ |
|---|---|
| Device Name | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Regulation | 21 CFR 862.1680 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
Classification Rationale
Class I.
Recent Cleared Devices (20 of 89)
Showing 20 most recent of 89 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | Apr 15, 2026 | SESE |
| K240865 | IDS-iSYS Free Testosterone | Immunodiagnostic Systems Limited | Oct 23, 2024 | SESE |
| K233480 | Access SHBG | Beckman Coulter, Inc. | Feb 8, 2024 | SESE |
| K223405 | Access Testosterone | Beckman Coulter, Inc. | Jan 13, 2023 | SESE |
| K211685 | Elecsys Testosterone II | Roche Diagnostics | May 6, 2022 | SESE |
| K201908 | LIAISON Testosterone xt | DiaSorin, Inc. | Oct 15, 2020 | SESE |
| K191350 | ACTIVE® Free Testosterone RIA | Immunotech S.R.O. | Dec 20, 2019 | SESE |
| K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics, Inc. | Aug 28, 2019 | SESE |
| K190121 | IDS SHBG | Immunodiagnostic Systems , Ltd. | Jun 17, 2019 | SESE |
| K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | Qualigen, Inc. | Jan 29, 2019 | SESE |
| K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | Jul 20, 2018 | SESE |
| K153577 | FREND Testosterone Test System | Nanoentek USA, Inc. | Oct 14, 2016 | SESE |
| 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 | Siemens Healthcare Diagnostics, Inc. | Jun 29, 2016 | SESE |
| K152185 | ARCHITECT SHBG | Biokit, S.A. | Feb 11, 2016 | SESE |
| K151529 | Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator | Siemens Healthcare Diagnostics, Inc. | Feb 11, 2016 | SESE |
| K152155 | ARCHITECT 2nd Generation Testosterone | Abbott Laboratories | Dec 17, 2015 | SESE |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | Tosoh Bioscience, Inc. | Jul 2, 2015 | SESE |
| K133491 | ADVIA CENTAUR TESTOSTERONE (TSTO) | Siemens Healthcare Diagnostics, Inc. | Feb 21, 2014 | SESE |
| K122793 | LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET | DiaSorin, Inc. | Jan 25, 2013 | SESE |
| K120009 | TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) | Abbott Laboratories | Sep 11, 2012 | SESE |
Top Applicants
- Diagnostic Products Corp. — 9 clearances
- Diagnostic Systems Laboratories, Inc. — 7 clearances
- Beckman Coulter, Inc. — 4 clearances
- Leeco Diagnostics, Inc. — 4 clearances
- Siemens Healthcare Diagnostics, Inc. — 4 clearances
