ACE CEDIA Cortisol Assay

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K943427 ↗

FDA Product Code

CGR

Device Class

Class II

Regulation

21 CFR Part 862.1205

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What types of biological samples can the ACE CEDIA Cortisol Assay measure cortisol levels in, and how is it primarily used in clinical settings?

  The ACE CEDIA Cortisol Assay is designed to measure cortisol levels in various biological samples, such as blood, urine, or saliva, though the exact sample types are not specified beyond its role as an in vitro diagnostic tool. It is primarily used in clinical chemistry laboratories to aid in diagnosing and monitoring endocrine disorders, stress responses, and adrenal function by quantifying cortisol (hydrocortisone and corticosterone) secreted by the adrenal glands.

• Is the ACE CEDIA Cortisol Assay intended for single-use or can it be reused, and how should it be stored?

  The ACE CEDIA Cortisol Assay is not a single-use or reusable device, as explicitly stated in the product description. Since it is a combination product for in vitro diagnostic use, storage instructions are not detailed in the provided data, but it would typically require adherence to manufacturer guidelines for radioimmunoassay kits, which often involve refrigeration or freezing to maintain stability and sterility until use.

• What regulatory pathway was used for the FDA clearance of this assay, and which advisory committee reviewed it?

  The ACE CEDIA Cortisol Assay was cleared through the Traditional 510(k) pathway with a Substantially Equivalent determination, as indicated by the decision code *SESE*. The review was conducted by the Clinical Chemistry (CH) Advisory Committee, which evaluates submissions for radioimmunoassays and related diagnostic tools under the CGR product code.

• What is the primary purpose of this assay, and what clinical chemistry applications does it support?

  The primary purpose of the ACE CEDIA Cortisol Assay is to quantify cortisol levels in biological samples, which helps clinicians diagnose and monitor conditions like adrenal dysfunction, endocrine disorders, and stress-related responses. It falls under the Clinical Chemistry specialty, supporting laboratory-based diagnostics where precise cortisol measurement is critical for patient management.