Fluorometric, Cortisol
FDA product code JFT · Class II (moderate risk) · 21 CFR 862.1205 · Clinical Chemistry
20510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Roche Diagnostics Corp. 3
- Abbott Laboratories 2
- Ciba Corning Diagnostics Corp. 2
- Siemens Healthcare Diagnostics, Inc. 2
- Syva Co. 1
- Lkb Instruments, Inc. 1
- Microgenics Corp. 1
- Baxter Healthcare Corp 1
- Kallestad Diag, A Div. of Erbamont, Inc. 1
- Bio-Rad Laboratories, Inc. 1
- Wallac OY 1
- Biomerieux Vitek, Inc. 1
- Tosoh Medics, Inc. 1
- Fujirebio Diagnostics,Inc. 1
- Seradyn, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242505 | Elecsys Cortisol IIIJFT · Traditional | Roche Diagnostics | 07/17/2025SE |
| K192788 | ADVIA Centaur Cortisol (COR)JFT · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/25/2019SE |
| K152227 | Elecsys Cortisol II, Cortisol II CalSetJFT · Traditional | Roche Diagnostics | 04/27/2016SE |
| K142723 | ADVIA Centaur Cortisol (COR) AssyJFT · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/31/2015SE |
| K062204 | Architect Cortisol AssayJFT · Traditional | Seradyn, Inc. | 09/22/2006SE |
| K033731 | Axsym Cortisol AssayJFT · Traditional | Fujirebio Diagnostics,Inc. | 02/20/2004SE |
| K021218 | Elecsys Cortisol Test SystemJFT · Traditional | Roche Diagnostics Corp. | 09/09/2002SE |
| K962559 | Acs Cortisol ImmunoassayJFT · Traditional | Ciba Corning Diagnostics Corp. | 11/05/1996SE |
| K954591 | Aia-Pack Cort AssayJFT · Traditional | Tosoh Medics, Inc. | 12/15/1995SE |
| K934317 | Cidba Corning Acs Cortisol ImmunoassayJFT · Traditional | Ciba Corning Diagnostics Corp. | 05/13/1994SE |
| K931031 | Vidas Cortisol (Cort) Assay & Serum Free DilutentJFT · Traditional | Biomerieux Vitek, Inc. | 07/27/1993SE |
| K930732 | Delfia Cortisol KitJFT · Traditional | Wallac OY | 07/27/1993SE |
| K926322 | Access(R) Cortisol ReagentsJFT · Traditional | Bio-Rad Laboratories, Inc. | 05/26/1993SE |
| K900010 | NDS Cortisol Test Kit and NDS Cortisol CalibratorJFT · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 04/03/1990SE |
| K895421 | Cortisol Test SystemJFT · Traditional | Baxter Healthcare Corp | 12/07/1989SE |
| K893954 | Cedia Cortisol AssayJFT · Traditional | Microgenics Corp. | 10/31/1989SE |
| K863422 | Delfia(Tm) Cortisol KitJFT · Traditional | Lkb Instruments, Inc. | 09/26/1986SE |
| K854419 | TDX CortisolJFT · Traditional | Abbott Laboratories | 11/25/1985SE |
| K852927 | TDX CortisolJFT · Traditional | Abbott Laboratories | 08/05/1985SE |
| K833932 | Syva Advance Cortisol AssayJFT · Traditional | Syva Co. | 12/29/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1505-2023 Class II | ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T…There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results… | Siemens Healthcare Diagnostics, Inc. | 03/16/2023Open, Classified |
| Z-1504-2023 Class II | Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537)…There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results… | Siemens Healthcare Diagnostics, Inc. | 03/16/2023Open, Classified |
| Z-2094-2018 Class II | ST-AIA PACK Cort; Part Number: 025287 Assay, MetabolicAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-1390-2012 | Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit…Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims | Siemens Healthcare Diagnostics, Inc | 03/06/2012Terminated |