Cortisol Saliva Luminescence Immunoassay
FDA 510(k) K150528 · Ibl International GmbH
510(k) numberK150528
Submission
- Device name
- Cortisol Saliva Luminescence Immunoassay
- Applicant
- Ibl International GmbH
Hamburg, DE - Received
- March 2, 2015
- Decision date
- November 25, 2015
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102841 | Pantex Am/Pm Salivary Cortisol Enzyme ImmunoassayNHG · Traditional | Pantex, Div. Bio-Analysis, Inc. | 05/08/2012SE |
| K070788 | Elecsys Cortisol Test SystemNHG · Traditional | Roche Diagnostics | 10/05/2007SE |
| 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 |
Questions and answers
When was Cortisol Saliva Luminescence Immunoassay cleared by the FDA?
Cortisol Saliva Luminescence Immunoassay (K150528) received a 510(k) decision of Substantially Equivalent on November 25, 2015, 268 days after the submission was received.
What is the product code of K150528?
The FDA product code is NHG – Enzyme Immunoassay, Cortisol, Salivary, a Class II (moderate risk) device regulated under 21 CFR 862.1205.