K043175 is an FDA 510(k) clearance for the ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE. This device is classified as a Enzyme Immunoassay, Cortisol, Salivary (Class II - Special Controls, product code NHG).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 24, 2004, 8 days after receiving the submission on November 16, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1205. 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..
| 510(k) Number | K043175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2004 |
| Decision Date | November 24, 2004 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NHG — Enzyme Immunoassay, Cortisol, Salivary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1205 |
| Definition | 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. |