IDS-iSYS Total Testosterone
FDA 510(k) K252728 · Immunodiagnostic Systems Limited
510(k) numberK252728
Submission
- Device name
- IDS-iSYS Total Testosterone
- Applicant
- Immunodiagnostic Systems Limited
Tyne & Wear, GB - Received
- August 28, 2025
- Decision date
- April 15, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1680
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Monobind, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K240865 | IDS-iSYS Free TestosteroneCDZ · Traditional | 10/23/2024SE |
| K223867 | Ids Acth IICKG · Traditional | 08/18/2023SE |
| K202136 | IDS CortisolCGR · Traditional | 04/13/2021SE |
| K200475 | IDS-iSYS Ostase BAPCIN · Traditional | 09/30/2020SE |
| K190121 | Ids SHBGCDZ · Traditional | 06/17/2019SE |
| K161158 | IDS-iSYS Intact PTHNCEW · Traditional | 01/31/2017SE |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetMRG · Traditional | 11/15/2016SE |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX · Traditional | 05/17/2016SE |
| K142351 | 25-Hydroxy Vitamin Ds EIAMRG · Traditional | 08/25/2015SE |
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…CJM · Traditional | 04/21/2015SE |
Questions and answers
When was IDS-iSYS Total Testosterone cleared by the FDA?
IDS-iSYS Total Testosterone (K252728) received a 510(k) decision of Substantially Equivalent on April 15, 2026, 230 days after the submission was received.
What is the product code of K252728?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.