Aldosterone Radioimmunoassay Test Kit
by Serono Laboratories, Inc. 510(k)
Active
510(k) K834428
Overview
This device is a radioimmunoassay test kit for aldosterone, classified under FDA product code CJM and regulatory category 21 CFR 862.1045. It is an in-vitro diagnostic tool designed to quantitatively measure aldosterone levels in serum and urine samples, aiding in clinical chemistry assessments. Aldosterone assays are critical for diagnosing and monitoring conditions such as primary aldosteronism, hypertension, and adrenal disorders. The test kit employs radioimmunoassay technology to detect and quantify hormone concentrations with precision.
The Aldosterone Radioimmunoassay Test Kit is supplied as a single-use diagnostic reagent system, intended for use in clinical laboratory settings by trained personnel. It requires no special storage conditions beyond those specified in the accompanying instructions, though handling radioactive materials necessitates adherence to radiation safety protocols. The kit received FDA 510(k) clearance (K834428) under the Traditional 510(k) Review pathway, determined to be Substantially Equivalent to a predicate device. No additional regulatory markings (e.g., CE marking) are indicated in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK834428 | Date2 Mar 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CJM
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1045
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Serono Laboratories, Inc.
Questions
What clinical conditions is this test kit designed to help diagnose or monitor?
This Aldosterone Radioimmunoassay Test Kit is specifically developed to quantitatively measure aldosterone levels in serum and urine samples. It aids in diagnosing and monitoring conditions such as primary aldosteronism, hypertension, and adrenal disorders, where aldosterone levels play a key role in clinical assessment.
Is this test kit intended for single-use or reusable applications?
The Aldosterone Radioimmunoassay Test Kit is supplied as a single-use diagnostic reagent system. This design ensures precision and safety, particularly given the handling of radioactive materials, which necessitates adherence to strict radiation safety protocols per the manufacturer’s instructions.
What type of samples can be tested with this kit, and how is it used?
This kit is designed for in-vitro diagnostic use in clinical laboratory settings by trained personnel. It quantitatively measures aldosterone concentrations in both serum and urine samples, providing critical data for clinical chemistry assessments.
Are there any special storage requirements for this test kit beyond standard laboratory conditions?
The kit does not require special storage conditions beyond those outlined in the accompanying instructions. However, because it involves radioactive materials, strict adherence to radiation safety protocols is mandatory during handling and storage to ensure user and environmental safety.
What regulatory pathway was followed for FDA clearance of this device?
The Aldosterone Radioimmunoassay Test Kit received FDA 510(k) clearance under the Traditional 510(k) Review pathway, determined to be Substantially Equivalent (SESE) to a predicate device. The clearance number is K834428, and it falls under FDA product code CJM and regulatory category 21 CFR 862.1045.