IBL CORTISOL LIA TEST KIT

• K Number: K052359
• Device Name: IBL CORTISOL LIA TEST KIT
• Manufacturer: Lehnus & Associates Consulting
• Date Cleared: 2005-10-03 ( 38 days)
• Product Code: CGR
• Regulation Number: 862.1205
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

The IBL Cortisol Luminescence Immunoassay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva.

The Cortisol LIA kit is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease.

Device Description

IBL Cortisol LIA test kit

AI/ML Overview

This is an FDA Premarket Notification (510(k)) letter for the IBL Cortisol LIA test kit. The letter itself does not contain the detailed acceptance criteria or the study results. It primarily states that the device has been found substantially equivalent to a predicate device.

Therefore, I cannot provide the requested information from the provided text because it is not present in this document. The document confirms that the device is cleared for marketing but does not detail the technical performance studies and acceptance criteria that led to that clearance.

Regulation Number and Section

§ 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.