Adrenocorticotropic/Acth Analysis Product

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K926396 ↗

FDA Product Code

CKG

Device Class

Class II

Regulation

21 CFR Part 862.1025

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Nichols ACTH radioimmunoassay kit used for?

  This kit is designed for the quantitative analysis of adrenocorticotropic hormone (ACTH) in clinical chemistry applications. By measuring ACTH levels in serum or plasma, it supports the diagnosis and monitoring of conditions such as adrenal insufficiency, Cushing’s syndrome, and pituitary disorders. The immunochemical technique ensures precise detection, helping clinicians assess hormonal imbalances.

• How is the Nichols ACTH radioimmunoassay kit supplied and used?

  The kit is supplied as a single-use reagent kit, intended for laboratory processing only. It requires specialized equipment and trained personnel to perform the radioimmunoassay procedure. The instructions provided with the kit outline the steps for accurate measurement, including sample preparation, incubation, and detection phases, ensuring reliable results for clinical decision-making.

• Is the Nichols ACTH radioimmunoassay kit sterile, and how should it be stored?

  The kit does not specify any claims regarding sterility, so standard laboratory protocols for immunoassay reagents should be followed. Storage should adhere to manufacturer guidelines, typically involving refrigeration (2–8°C) and protection from light and moisture. Always check the included documentation for precise storage instructions to maintain reagent integrity and accuracy.

• Can the Nichols ACTH radioimmunoassay kit be reused, and what sizes or models are available?

  The kit is explicitly designed for single-use only, as indicated in the product description. While multiple FEI numbers are listed in regulatory records, these pertain to administrative categorization (e.g., product codes) rather than distinct sizes or models of the kit itself. The primary distinction lies in the product code CKG under the Clinical Chemistry category, ensuring compliance with FDA regulations.

• What regulatory pathway does the Nichols ACTH radioimmunoassay kit follow?

  This kit was granted FDA 510(k) clearance (K926396) under the Traditional 510(k) pathway in 1993, classified as substantially equivalent to a predicate device. It falls under FDA regulation 862.1025 and is categorized under Clinical Chemistry (product code CKG). The clearance was reviewed by the Clinical Chemistry (CH) Advisory Committee, confirming its compliance with safety and effectiveness standards for diagnostic use.