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510(k) K051733

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL by Drg Intl., Inc. — Product Code NHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2005
Date Received
June 28, 2005
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 by Drg Intl., Inc.

  • K062534 — ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE (January 29, 2008)
  • K052649 — DRG SLV TESTOSTERONE ELISA TEST (January 27, 2006)
  • K000043 — DRG AURICA ELISA TESTOSTERONE KIT (April 17, 2000)

Other clearances for product code NHG

  • K150528 — Cortisol Saliva Luminescence Immunoassay (November 25, 2015)
  • K102841 — PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY (May 8, 2012)
  • K070788 — ELECSYS CORTISOL TEST SYSTEM (October 5, 2007)
  • 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)