ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
FDA 510(k) clearance K043175 · decided 2004-11-24
Clearance details
- K-number
- K043175
- Device name
- ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-16
- Decision date
- 2004-11-24
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- NHG
- 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 |
|---|---|---|
| Cortisol Saliva Luminescence Immunoassay (K150528) | Ibl International GmbH | 2015-11-25 |
| PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY (K102841) | Pantex, Div. Bio-Analysis, Inc. | 2012-05-08 |
| ELECSYS CORTISOL TEST SYSTEM (K070788) | Roche Diagnostics | 2007-10-05 |
| ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL (K051733) | Drg Intl., Inc. | 2005-12-07 |
| HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY (K031348) | Salimetrics, LLC | 2003-06-10 |
| HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 (K011323) | Salimetrics, LLC | 2001-12-17 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys recall (Z-0977-2007) | Roche Diagnostics Corp. | 2007-06-28 |
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 |