Elecsys Cortisol II, Cortisol II CalSet
FDA 510(k) clearance K152227 · decided 2016-04-27
Clearance details
- K-number
- K152227
- Device name
- Elecsys Cortisol II, Cortisol II CalSet
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2015-08-07
- Decision date
- 2016-04-27
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- JFT
- Device class
- 2
- Regulation number
- 862.1205
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Elecsys Cortisol III (K242505) | Roche Diagnostics | 2025-07-17 |
| ADVIA Centaur Cortisol (COR) (K192788) | Siemens Healthcare Diagnostics, Inc. | 2019-11-25 |
| ADVIA Centaur Cortisol (COR) Assy (K142723) | Siemens Healthcare Diagnostics, Inc. | 2015-03-31 |
| ARCHITECT CORTISOL ASSAY (K062204) | Seradyn, Inc. | 2006-09-22 |
| AXSYM CORTISOL ASSAY (K033731) | Fujirebio Diagnostics,Inc. | 2004-02-20 |
| ELECSYS CORTISOL TEST SYSTEM (K021218) | Roche Diagnostics Corp. | 2002-09-09 |
| ACS CORTISOL IMMUNOASSAY (K962559) | Ciba Corning Diagnostics Corp. | 1996-11-05 |
| AIA-PACK CORT ASSAY (K954591) | Tosoh Medics, Inc. | 1995-12-15 |
| CIDBA CORNING ACS CORTISOL IMMUNOASSAY (K934317) | Ciba Corning Diagnostics Corp. | 1994-05-13 |
| DELFIA CORTISOL KIT (K930732) | Wallac OY | 1993-07-27 |
| VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT (K931031) | Biomerieux Vitek, Inc. | 1993-07-27 |
| ACCESS(R) CORTISOL REAGENTS (K926322) | Bio-Rad Laboratories, Inc. | 1993-05-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |