Elecsys Cortisol Test System
FDA 510(k) K070788 · Roche Diagnostics
510(k) numberK070788
Submission
- Device name
- Elecsys Cortisol Test System
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- March 22, 2007
- Decision date
- October 5, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| K150528 | Cortisol Saliva Luminescence ImmunoassayNHG · Traditional | Ibl International GmbH | 11/25/2015SE |
| K102841 | Pantex Am/Pm Salivary Cortisol Enzyme ImmunoassayNHG · Traditional | Pantex, Div. Bio-Analysis, Inc. | 05/08/2012SE |
| K051733 | Enzyme Immunoassay for the Detection of Salivary CortisolNHG · Traditional | Drg Intl., Inc. | 12/07/2005SE |
| K043175 | Elecsys Cortisol Test System, Addition of Saliva Sample TypeNHG · Traditional | Roche Diagnostics Corp. | 11/24/2004SE |
| K031348 | High Sensitivity Cortisol Enzyme ImmunoassayNHG · Special | Salimetrics, LLC | 06/10/2003SE |
| K011323 | High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102NHG · Traditional | Salimetrics, LLC | 12/17/2001SE |
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Questions and answers
When was Elecsys Cortisol Test System cleared by the FDA?
Elecsys Cortisol Test System (K070788) received a 510(k) decision of Substantially Equivalent on October 5, 2007, 197 days after the submission was received.
What is the product code of K070788?
The FDA product code is NHG – Enzyme Immunoassay, Cortisol, Salivary, a Class II (moderate risk) device regulated under 21 CFR 862.1205.