TDX CORTISOL
FDA 510(k) clearance K854419 · decided 1985-11-25
Clearance details
- K-number
- K854419
- Device name
- TDX CORTISOL
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1985-11-04
- Decision date
- 1985-11-25
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- JFT
- Device class
- 2
- Regulation number
- 862.1205
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Abbott Park, IL, 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 |
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, recall (Z-0723-04) | Abbott Laboratories HPD/ADD/GPRD | 2004-07-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |