NHG — Enzyme Immunoassay, Cortisol, Salivary Class II
Classification Details
- Product Code
- NHG
- Device Class
- Class II
- Regulation Number
- 862.1205
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease. This kit is not intended for use with serum or plasma samples. The device's intended use differs from the description in the classification regulation in that it is for use with saliva samples.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K150528 | ibl international | Cortisol Saliva Luminescence Immunoassay | November 25, 2015 |
| K102841 | pantex, div. bio-analysis | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY | May 8, 2012 |
| K070788 | roche diagnostics | ELECSYS CORTISOL TEST SYSTEM | October 5, 2007 |
| K051733 | drg intl | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL | December 7, 2005 |
| K043175 | roche diagnostics | ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE | November 24, 2004 |
| K031348 | salimetrics | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY | June 10, 2003 |
| K011323 | salimetrics | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 | December 17, 2001 |