ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
FDA 510(k) K191533 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK191533
Submission
- Device name
- ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- June 10, 2019
- Decision date
- August 28, 2019
- 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
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|---|---|---|---|
| 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 |
| 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 |
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| K253528 | Atellica IM CA 19-9 IINIG · Traditional | 08/10/2026SE |
| K261364 | Atellica CH Acetaminophen 2 (ACTM)LDP · Traditional | 07/24/2026SE |
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | 02/27/2026SE |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII)JLW · Traditional | 02/06/2026SE |
| K251630 | Atellica IM Total PSA II (tPSAII)LTJ · Traditional | 01/05/2026SE |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII)JNL · Traditional | 12/04/2025SE |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase IIJZO · Traditional | 10/17/2025SE |
| K242981 | Atellica IM Thyroglobulin (Tg)MSW · Traditional | 06/20/2025SE |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…JLW · Traditional | 04/25/2025SE |
| K242685 | Atellica® CH Creatinine_3 (Crea3)CGX · Traditional | 12/04/2024SE |
Questions and answers
When was ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG cleared by the FDA?
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (K191533) received a 510(k) decision of Substantially Equivalent on August 28, 2019, 79 days after the submission was received.
What is the product code of K191533?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.