DSL Active Aldosterone (DSL 8600)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K921205 ↗

FDA Product Code

CJM

Device Class

Class II

Regulation

21 CFR Part 862.1045

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Diagnostic Systems Laboratories, Inc. →

• What is the DSL Active Aldosterone (DSL 8600) test system used for?

  The DSL Active Aldosterone (DSL 8600) test system is intended to measure the hormone aldosterone in serum and urine samples. It is used in the diagnosis and treatment of primary aldosteronism and hypertension caused by primary aldosteronism, helping clinicians assess hormone levels linked to these conditions.

• How is the DSL Active Aldosterone (DSL 8600) supplied and where is it used?

  The DSL Active Aldosterone (DSL 8600) is supplied as a radioimmunoassay test system for use in clinical laboratory settings. It is designed for laboratory professionals to process serum and urine specimens to quantify aldosterone levels as part of diagnostic workflows.

• What regulatory pathway was used for the DSL Active Aldosterone (DSL 8600) clearance?

  The DSL Active Aldosterone (DSL 8600) received FDA 510(k) clearance under submission number K921205, which was processed as a traditional 510(k) and found substantially equivalent to a legally marketed predicate device. This clearance allows its commercial distribution in the United States.