High Sensitivity Cortisol Enzyme Immunoassay

FDA 510(k) K031348 · Salimetrics, LLC

Substantially Equivalent

510(k) numberK031348

Submission

Device name
High Sensitivity Cortisol Enzyme Immunoassay
Applicant
Salimetrics, LLC
State College, PA, US
Received
April 11, 2003
Decision date
June 10, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 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…

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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
K011323High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102NHG · Traditional Salimetrics, LLC12/17/2001SE

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K051012Progesterone Standard Calibrator, One (1) ML of Progesterone in a Saliva-Like Matrix at…JIT · Traditional 07/19/2005SE
K011323High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102NHG · Traditional 12/17/2001SE

Questions and answers

When was High Sensitivity Cortisol Enzyme Immunoassay cleared by the FDA?

High Sensitivity Cortisol Enzyme Immunoassay (K031348) received a 510(k) decision of Substantially Equivalent on June 10, 2003, 60 days after the submission was received.

What is the product code of K031348?

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