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510(k) K102841

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

K102841 is an FDA 510(k) premarket notification submitted by Pantex, Div. Bio-Analysis, Inc. for the device "PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on May 8, 2012. The device falls under product code NHG (Enzyme Immunoassay, Cortisol, Salivary), a Class II device regulated under 21 CFR 862.1205. Pantex, Div. Bio-Analysis, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K942658 — NEOSCREEN ELISA TSH (February 24, 1995)
  • 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)

FDA data resources