510(k) K043175
K043175 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE". The FDA issued a decision of Substantially Equivalent on November 24, 2004. The device falls under product code NHG (Enzyme Immunoassay, Cortisol, Salivary), a Class II device regulated under 21 CFR 862.1205. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2004
- Date Received
- November 16, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Cortisol, Salivary
- Device Class
- Class II
- Regulation Number
- 862.1205
- Review Panel
- CH
- Submission Type
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 is for use with saliva samples.