ELECSYS CORTISOL TEST SYSTEM
FDA 510(k) clearance K021218 · decided 2002-09-09
Clearance details
- K-number
- K021218
- Device name
- ELECSYS CORTISOL TEST SYSTEM
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-17
- Decision date
- 2002-09-09
- Days to decision
- 145 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 |
| Elecsys Cortisol II, Cortisol II CalSet (K152227) | Roche Diagnostics | 2016-04-27 |
| 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 |
| 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 FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043) | Roche Diagnostics Corp. | 2025-05-27 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044) | Roche Diagnostics Corp. | 2025-05-27 |
| Elecsys Anti-HBc II (P100031/S033) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc II (P100032/S023) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110031/S027) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110022/S034) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBs (P010054/S048) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025) | Roche Diagnostics Corp. | 2024-11-22 |