510(k) K102841

PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY by Pantex, Div. Bio-Analysis, Inc. — Product Code NHG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 8, 2012
Date Received: September 29, 2010
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 Pantex, Div. Bio-Analysis, Inc.

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K914107 — PROLACTIN IRMA IMMUNOMAG (September 30, 1991)
K912804 — FSH IRMA IMMUNOMAG (August 12, 1991)
K911839 — NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT (June 18, 1991)
K911050 — LH IRMA IMMUNOMAG (April 12, 1991)
K910717 — PANTEX IRMA LH 1251 KIT (March 19, 1991)
K894049 — IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT (September 8, 1989)
K862483 — PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT (January 14, 1987)
K862447 — PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT (October 7, 1986)
K862336 — PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT (September 25, 1986)

Other clearances for product code NHG

K150528 — Cortisol Saliva Luminescence Immunoassay (November 25, 2015)
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)