Enzyme Immunoassay, Cortisol, Salivary
Clinical Chemistry · 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.
Recent MDR events
20 adverse event reports on file
- ELECSYS CORTISOLMay 1, 2024MalfunctionRoche Diagnostics1823260-2024-01328
- ELECSYS CORTISOLOct 10, 2023MalfunctionRoche Diagnostics1823260-2023-03242
- ELECSYS CORTISOL TEST SYSTEMAug 6, 2021MalfunctionRoche Diagnostics1823260-2021-02295
- ELECSYS CORTISOL TEST SYSTEMJan 26, 2021MalfunctionRoche Diagnostics1823260-2021-00266
- ELECSYS CORTISOL TEST SYSTEMSep 17, 2019MalfunctionRoche Diagnostics1823260-2019-03346
- CORTISOLJan 5, 2018MalfunctionRoche Diagnostics1823260-2018-00079
- ELECSYS CORTISOL TEST SYSTEMAug 9, 2017MalfunctionRoche Diagnostics1823260-2017-01653
- CORTISOLAug 5, 2016MalfunctionRoche Diagnostics1823260-2016-01115
- CORTISOLJul 22, 2016MalfunctionRoche Diagnostics1823260-2016-01034
- CORTISOLMay 20, 2016MalfunctionRoche Diagnostics1823260-2016-00664
Event type breakdown
Most-reported manufacturers
Recalls
5 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Adrenal Test
Distribution without premarket approval/clearance.
Z-0772-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Women s Hormone Test
Distribution without premarket approval/clearance.
Z-0798-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Allergy test Small
Distribution without premarket approval/clearance.
Z-0804-2026 · View FDA record ↗ - Roche Diagnostics Corp.TerminatedJun 28, 2007
Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no. 118751161
The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.
Z-0977-2007 · View FDA record ↗ - Tecan US, Inc.TerminatedUnknown
Cortisol Saliva Luminescence Immunoassay
Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard.
Z-2923-2018 · View FDA record ↗
Registered firms
5 firms currently registered for this product code
510(k) clearances
7 clearances for this product code
- Ibl International GmbHNov 25, 2015
K150528 · Cortisol Saliva Luminescence Immunoassay
- Pantex, Div. Bio-Analysis, Inc.May 8, 2012
K102841 · PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
- Roche DiagnosticsOct 5, 2007
K070788 · ELECSYS CORTISOL TEST SYSTEM
- Drg Intl., Inc.Dec 7, 2005
K051733 · ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
- Roche Diagnostics Corp.Nov 24, 2004
K043175 · ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
- Salimetrics, LLCJun 10, 2003
K031348 · HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY
- Salimetrics, LLCDec 17, 2001
K011323 · HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102