Elecsys Cortisol Test System, Addition of Saliva Sample Type
FDA 510(k) K043175 · Roche Diagnostics Corp.
Submission
- Device name
- Elecsys Cortisol Test System, Addition of Saliva Sample Type
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- November 16, 2004
- Decision date
- November 24, 2004
- 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 |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
More from Salimetrics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Elecsys Cortisol Test System, Addition of Saliva Sample Type cleared by the FDA?
Elecsys Cortisol Test System, Addition of Saliva Sample Type (K043175) received a 510(k) decision of Substantially Equivalent on November 24, 2004, 8 days after the submission was received.
What is the product code of K043175?
The FDA product code is NHG – Enzyme Immunoassay, Cortisol, Salivary, a Class II (moderate risk) device regulated under 21 CFR 862.1205.