Adrenocorticotropic hormone (ACTH) test system

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I3CGlobal IVDR, FDA 510k

FDA 510K for Adrenocorticotropic Hormone (ACTH) Test System

An Adrenocorticotropic Hormone (ACTH) Test System measures ACTH levels in blood to evaluate adrenal and pituitary function. ACTH is a hormone produced by the pituitary gland that stimulates the adrenal glands to release cortisol. The test helps diagnose conditions like Cushing’s syndrome, Addison’s disease, and secondary adrenal insufficiency.

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FDA 510K for Adrenocorticotropic Hormone (ACTH) Test System Device Code and Regulation Number

Intended use of Adrenocorticotropic Hormone (ACTH) Test System

An Adrenocorticotropic Hormone (ACTH) Test System is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing’s Syndrome, Adrenocortical Insufficiency, and the Ectopic ACTH Syndrome.

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 Product Code Device Regulation Description Regulation Number Device Class
1. CKG Radioimmunoassay, ACTH Adrenocorticotropic Hormone (ACTH) Test System
862.1025		 Class II

 

Radioimmunoassay, ACTH

Intended Use

IDS ACTH II assay is an automated in vitro diagnostic device intended for the quantitative, determination of ACTH in human K2 and K3 EDTA plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the assessment of pituitary and adrenal gland function and the differential diagnosis of hyper and hypo-cortisolism.

Device Description

The IDS ACTH II assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:

  • MP: Magnetic particles coated with mouse monoclonal antiACTH antibody and buffer containing phosphate with blocking proteins and ProClin 300 as preservative.
  • R1: Mouse monoclonal anti-ACTH antibody labelled with an acridinium ester derivative, in buffer containing phosphate with BSA and ProClin 300 as preservative.
  • R2: Buffer containing phosphate with blocking proteins and ProClin 300 as preservative.

Performance Testing (Analytical) for Adrenocorticotropic Hormone (ACTH) Test System

  • Limit of blank (LoB)
  • Limit of detection (LoD)
  • Limit of quantitation (LoQ)
  • Precision (Repeatability/Reproducibility)
  • Linearity
  • Analytical specificity
  • Interference
  • Cross-reactivity
  • Method comparison
  • Matrix comparison
  • Expected values

Clinical Testing

Not required for 510(k) submission

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