High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102

FDA 510(k) K011323 · Salimetrics, LLC

Substantially Equivalent

510(k) numberK011323

Submission

Device name
High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102
Applicant
Salimetrics, LLC
State College, PA, US
Received
May 1, 2001
Decision date
December 17, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHG – Enzyme Immunoassay, Cortisol, Salivary
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1205
Specialty
Clinical Chemistry

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…

Other 510(k)s with product code NHG

510(k)DeviceApplicantDecision
K150528Cortisol Saliva Luminescence ImmunoassayNHG · Traditional Ibl International GmbH11/25/2015SE
K102841Pantex Am/Pm Salivary Cortisol Enzyme ImmunoassayNHG · Traditional Pantex, Div. Bio-Analysis, Inc.05/08/2012SE
K070788Elecsys Cortisol Test SystemNHG · Traditional Roche Diagnostics10/05/2007SE
K051733Enzyme Immunoassay for the Detection of Salivary CortisolNHG · Traditional Drg Intl., Inc.12/07/2005SE
K043175Elecsys Cortisol Test System, Addition of Saliva Sample TypeNHG · Traditional Roche Diagnostics Corp.11/24/2004SE
K031348High Sensitivity Cortisol Enzyme ImmunoassayNHG · Special Salimetrics, LLC06/10/2003SE

More from Salimetrics, LLC

510(k)DeviceDecision
K051012Progesterone Standard Calibrator, One (1) ML of Progesterone in a Saliva-Like Matrix at…JIT · Traditional 07/19/2005SE
K031348High Sensitivity Cortisol Enzyme ImmunoassayNHG · Special 06/10/2003SE

Questions and answers

When was High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102 cleared by the FDA?

High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102 (K011323) received a 510(k) decision of Substantially Equivalent on December 17, 2001, 230 days after the submission was received.

What is the product code of K011323?

The FDA product code is NHG – Enzyme Immunoassay, Cortisol, Salivary, a Class II (moderate risk) device regulated under 21 CFR 862.1205.