Enzyme Immunoassay, Cortisol, Salivary
The Enzyme Immunoassay, Cortisol, Salivary (product code NHG) is an in vitro diagnostic kit for the quantitative measurement of cortisol in saliva, used to assess adrenal function, stress response, and conditions such as Cushing's syndrome or adrenal insufficiency, as described in its definition. It is classified as an FDA Class 2 device within the Clinical Chemistry specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
Research product code NHG in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NHG
- Device Class
- FDA class 2
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150528 | Cortisol Saliva Luminescence Immunoassay | Nov 25, 2015 | Substantially Equivalent | Ibl International GmbH |
| K102841 | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY | May 08, 2012 | Substantially Equivalent | Pantex, Div. Bio-Analysis, Inc. |
| K070788 | ELECSYS CORTISOL TEST SYSTEM | Oct 05, 2007 | Substantially Equivalent | Roche Diagnostics |
| K051733 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL | Dec 07, 2005 | Substantially Equivalent | Drg Intl., Inc. |
| K043175 | ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE | Nov 24, 2004 | Substantially Equivalent | Roche Diagnostics Corp. |
| K031348 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY | Jun 10, 2003 | Substantially Equivalent | Salimetrics, LLC |
| K011323 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 | Dec 17, 2001 | Substantially Equivalent | Salimetrics, LLC |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.