NHG · Enzyme Immunoassay, Cortisol, Salivary
Clinical Chemistry · 21 CFR 862.1205 · Class 2
Overview
| Product Code | NHG |
|---|---|
| Device Name | Enzyme Immunoassay, Cortisol, Salivary |
| Regulation | 21 CFR 862.1205 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Classification Rationale
Class II.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150528 | Cortisol Saliva Luminescence Immunoassay | Ibl International GmbH | Nov 25, 2015 | SESE |
| K102841 | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY | Pantex, Div. Bio-Analysis, Inc. | May 8, 2012 | SESE |
| K070788 | ELECSYS CORTISOL TEST SYSTEM | Roche Diagnostics | Oct 5, 2007 | SESE |
| K051733 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL | Drg Intl., Inc. | Dec 7, 2005 | SESE |
| K043175 | ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE | Roche Diagnostics Corp. | Nov 24, 2004 | SESE |
| K031348 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY | Salimetrics, LLC | Jun 10, 2003 | SESE |
| K011323 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 | Salimetrics, LLC | Dec 17, 2001 | SESE |
Top Applicants
- Salimetrics, LLC — 2 clearances
- Drg Intl., Inc. — 1 clearance
- Ibl International GmbH — 1 clearance
- Pantex, Div. Bio-Analysis, Inc. — 1 clearance
- Roche Diagnostics — 1 clearance
