Enzyme Immunoassay for the Detection of Salivary Cortisol

FDA 510(k) K051733 · Drg Intl., Inc.

Substantially Equivalent

510(k) numberK051733

Submission

Device name
Enzyme Immunoassay for the Detection of Salivary Cortisol
Applicant
Drg Intl., Inc.
East Stroudsburg, PA, US
Received
June 28, 2005
Decision date
December 7, 2005
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…

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Questions and answers

When was Enzyme Immunoassay for the Detection of Salivary Cortisol cleared by the FDA?

Enzyme Immunoassay for the Detection of Salivary Cortisol (K051733) received a 510(k) decision of Substantially Equivalent on December 7, 2005, 162 days after the submission was received.

What is the product code of K051733?

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