Last synced on 2 December 2022 at 11:04 pm

Enzyme Immunoassay, Cortisol, Salivary

Page Type
Product Code
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.
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1205
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system

§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.

(a) Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

(b) Classification. Class II.

Enzyme Immunoassay, Cortisol, Salivary

Page Type
Product Code
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.
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1205
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system

§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.

(a) Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

(b) Classification. Class II.