17-OH-Progesterone ELISA

Primary DI

04049325029781

Basic UDI-DI Code

4049325IVR06080001BTF

Reference

RE52071

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

IBL International GmbH

Enzyme immunoassay for the in-vitro-diagnostic quantitative determination of 17-OH-Progesterone in human serum and EDTA plasma from women, men, and children. This test is intended as an aid to diagnosis and monitoring of congenital adrenal hyperplasia, in which 17-OH-Progesterone levels are found to be elevated in comparison with a corresponding population of apparently healthy individuals due to genetic 21-hydroxylase deficiency. Additionally, other clinical observations such as physical exams, quantification of other steroidal hormones (androstenedione and cortisol) and genetic testing are employed to assess the status of congenital adrenal hyperplasia. This test is intended as an aid to diagnosis and monitoring of late-onset congenital adrenal hyperplasia, in which 17-OH-Progesterone levels are found to be elevated in comparison with a corresponding population of apparently healthy individuals due to perturbations (21-hydroxylase deficiency, or androgen “backdoor” pathway) in the metabolism of 17-OH-Progesterone that leads to the accumulation of this steroid. Additionally, other clinical observations such as physical exams, quantification of other steroidal hormones (androstenedione, cortisol, and dihydrotestosterone), and genetic testing are employed to assess the status of late-onset congenital adrenal hyperplasia. In certain cases of congenital adrenal hyperplasia, 17-OH-Progesterone levels are quantified before and after stimulation with ACTH. The 17-OH-Progesterone ELISA is NOT appropriate for use in neonatal screening and for monitoring patients with hypogonadotropic hypogonadism. The test kit is intended for professional laboratory use by trained personnel. The test kit is not for home or layperson use.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).