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
FDA 510(k) clearance K151986 · decided 2016-06-29
Clearance details
- K-number
- K151986
- Device name
- 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
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-07-17
- Decision date
- 2016-06-29
- Days to decision
- 348 days
- Clearance type
- Traditional
- Product code
- CDZ
- Device class
- 1
- Regulation number
- 862.1680
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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| LIAISON Testosterone xt (K201908) | DiaSorin, Inc. | 2020-10-15 |
| ACTIVE® Free Testosterone RIA (K191350) | Immunotech S.R.O. | 2019-12-20 |
| ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (K191533) | Siemens Healthcare Diagnostics, Inc. | 2019-08-28 |
| IDS SHBG (K190121) | Immunodiagnostic Systems , Ltd. | 2019-06-17 |
| FastPack IP Sex Hormone Binding Globulin Immunoassay (K182521) | Qualigen, Inc. | 2019-01-29 |
| Free Testosterone AccuBind ELISA Test System (K181017) | Monobind, Inc. | 2018-07-20 |
| FREND Testosterone Test System (K153577) | Nanoentek USA, Inc. | 2016-10-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Atellica IM Total PSA II (tPSAII) (P240021) | Siemens Healthcare Diagnostics, Inc. | 2025-12-03 |
| IMMULITE 2000 PSA (P930027/S037) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| IMMULITE 2000 AFP (P010007/S024) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Atellica IM Anti-HBe2 (aHBe2) (P200017/S005) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Atellica IM HBc Total 2 (HBcT2) (P210019/S004) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036) | Siemens Healthcare Diagnostics, Inc. | 2025-08-14 |
| ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025) | Siemens Healthcare Diagnostics, Inc. | 2025-07-16 |