# K981607: Active Renin Irma Model Number DSL-25100

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: May 27, 1998 after 22 days
- Product code: CIB (Radioimmunoassay, Angiotensin I And Renin)
- Device class: 2
- Regulation: 21 CFR 862.1085
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Nichols Diagnostics ACTIVE Renin IRMA: named in the summary without a submission number

## Recalls of this device
- Jan 20, 2012 · Class II · Z-0016-2013: The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit a decrease in stability of the coated tubes. As a result, quality control and patient sam

## Indications for use
The DSL ACTIVE™ Renin Coated Tube IRMA assay is intended for the quantitative determination of Renin in human serum or plasma. This assay is intended for in vitro diagnostic use. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.

Source page: https://510kreport.com/device/K981607
Methodology: https://510kreport.com/methodology