Active Renin IRMA Model Number DSL-25100

• • Terminated Z-0016-2013 FDA Class II ·initiated 20 Jan 2012

  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 sample results may be falsely elevated by up to 72%.

510(k) Number

K981607 ↗

FDA Product Code

CIB

Device Class

Class II

Regulation

21 CFR Part 862.1085

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Diagnostic Systems Laboratories, Inc. →

• What is the primary function of the Active Renin IRMA DSL-25100?

  This device is a radioimmunoassay kit specifically designed for the quantitative measurement of renin within human plasma samples. It utilizes an immunoradiometric assay method to determine specific analyte levels in a clinical chemistry setting.

• What is the regulatory status of this device?

  The Active Renin IRMA DSL-25100 has received FDA 510(k) clearance. It is classified as a Class II medical device under regulation number 862.1085, which pertains to clinical chemistry test systems.

• Who is the manufacturer of the DSL-25100 kit?

  The device is supplied and manufactured by Diagnostic Systems Laboratories, Inc., based in Webster, Texas.