510(k) K150528

Cortisol Saliva Luminescence Immunoassay by Ibl International GmbH — Product Code NHG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 25, 2015
Date Received: March 2, 2015
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Enzyme Immunoassay, Cortisol, Salivary
Device Class: Class II
Regulation Number: 862.1205
Review Panel: CH
Submission Type

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.

Other clearances for product code NHG

K102841 — PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY (May 8, 2012)
K070788 — ELECSYS CORTISOL TEST SYSTEM (October 5, 2007)
K051733 — ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL (December 7, 2005)
K043175 — ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE (November 24, 2004)
K031348 — HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY (June 10, 2003)
K011323 — HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 (December 17, 2001)