Opus Ferritin Test System

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

510(k) Number

K915838 ↗

FDA Product Code

DGE

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Opus Napa

  Class II

  FDA 510(k) K934705 Active Cleared 22 Nov 1993

• Opus Tsh Test System

  Class II

  FDA 510(k) K902333 Active Cleared 5 Jul 1990

• Opus Digitoxin

  Class II

  FDA 510(k) K935229 Active Cleared 22 Dec 1993

• Opus Immunoassay System

  Class I

  FDA 510(k) K894159 Active Cleared 3 Aug 1989

• Opus FT4 Test System

  Class II

  FDA 510(k) K940507 Active Cleared 28 Jul 1994

• Opus Phenobarbital Test System

  Class II

  FDA 510(k) K896861 Active Cleared 11 Jan 1990

See all devices from Pb Diagnostic Systems, Inc. →

• What is the Opus Ferritin Test System used for in a clinical setting?

  The Opus Ferritin Test System is designed to measure ferritin levels in patient samples within a laboratory environment. Ferritin is a protein that stores iron in the body, and its levels are commonly assessed to evaluate iron stores, diagnose iron deficiency or overload conditions, and monitor certain diseases like hemochromatosis or anemia.

• Is the Opus Ferritin Test System intended for single-use or reusable applications?

  The Opus Ferritin Test System is not explicitly described as single-use or reusable in the provided data. However, since it is an immunology device for laboratory testing, it is typically designed for multiple uses with proper maintenance and cleaning protocols. For precise usage instructions, refer to the manufacturer’s guidelines.

• How is the Opus Ferritin Test System regulated by the FDA?

  The Opus Ferritin Test System received FDA 510(k) clearance on March 18, 1992, under product code DGE, which falls under the classification of a Class II medical device. This clearance was granted through a traditional review process by the Immunology (IM) Advisory Committee, confirming it is substantially equivalent to a predicate device.

• What type of laboratory setting is the Opus Ferritin Test System intended for?

  The Opus Ferritin Test System is explicitly designed for laboratory use, meaning it is intended for professional settings like clinical labs, diagnostic centers, or research facilities where trained personnel can perform ferritin measurements on patient samples. It is not intended for point-of-care or home use.