510(k) K252728
- Device
- IDS-iSYS Total Testosterone
- Applicant
- Immunodiagnostic Systems Limited
- 510(k) number
- K252728
- Product code
- CDZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-15
- Date received
- 2025-08-28
- Regulation
- 862.1680
- Classification name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Mick Henderson
- Address
- 10 Didcot Way Boldon Business Park Tyne & Wear GB NE35 9PD NE35 9PD
FDA Registration Numbers#
- 8010132
- 3006198300
- 3002800697
- 1063851
- 3007349751
- 3003030793
- 3003559191
- 9615037
- 2245285
- 3005333358
- 2432235
- 3010324880
- 3022178699
- 3012963943
- 2250051
- 1832216
- 8023018
- 3002809144
- 2182595
- 9612316
- 3007118747
- 2020726
- 1222302
- 8032314
- 1036362
- 2517506
- 2419955
- 3007361513
- 3009092698
- 2122870
- 2032087
- 8031673
- 1827821
- 3011989923
- 2032682
- 9610746
- 1415939
- 3033967997
- 3002642396
- 3005984081
- 2133982
- 8020888
- 1219913
- 3005529799
- 3007111389
- 9610126
- 2029372
- 9710337
- 3005542422
- 1319681
- 8021924
- 2018685
- 3000308930
- 3002806944
- 2032839
- 3004192065
Source Documents#
Other 510(k) Records For Product Code CDZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240865 | IDS-iSYS Free Testosterone | Immunodiagnostic Systems Limited | 2024-10-23 |
| K233480 | Access SHBG | Beckman Coulter, Inc. | 2024-02-08 |
| K223405 | Access Testosterone | Beckman Coulter, Inc. | 2023-01-13 |
| K211685 | Elecsys Testosterone II | Roche Diagnostics | 2022-05-06 |
| K201908 | LIAISON Testosterone xt | DiaSorin, Inc. | 2020-10-15 |
| K191350 | ACTIVE® Free Testosterone RIA | Immunotech S.R.O. | 2019-12-20 |
| K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics, Inc. | 2019-08-28 |
| K190121 | IDS SHBG | Immunodiagnostic Systems , Ltd. | 2019-06-17 |
| K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | Qualigen, Inc. | 2019-01-29 |
| K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | 2018-07-20 |
| K153577 | FREND Testosterone Test System | Nanoentek USA, Inc. | 2016-10-14 |
| 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. | 2016-06-29 |
| K151529 | Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator | Siemens Healthcare Diagnostics, Inc. | 2016-02-11 |
| K152185 | ARCHITECT SHBG | Biokit, S.A. | 2016-02-11 |
| K152155 | ARCHITECT 2nd Generation Testosterone | Abbott Laboratories | 2015-12-17 |