OPUS CEA Test System

No FDA recalls on record, checked 6 Oct 2026.

Full name

Opus(R) Cea Test System

Generic Name

SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

PMA Number

P920021 ↗

FDA Product Code

DHX

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

• Clibration Plasmas

  Class II

  FDA 510(k) K924404 Active Cleared 1 Dec 1992

• Opus Ck-Mb & Total Ck Controls

  Class I

  FDA 510(k) K960275 Active Cleared 25 Apr 1996

• D.A.T. (Tm) Amylase Reagent

  Class II

  FDA 510(k) K871943 Active Cleared 3 Jun 1987

• N/T Protein Control Sl

  Class I

  FDA 510(k) K964065 Active Cleared 6 Nov 1996

• Enzygnost(R) Anti-Cmv Igg

  Class II

  FDA 510(k) K913910 Active Cleared 28 Apr 1992

• N/T Rheumatology Control Sl/1 and Sl/2

  Class II

  FDA 510(k) K962373 Active Cleared 11 Jul 1996

See all devices from Behring Diagnostics, Inc. →

• What analyzers is the OPUS CEA Test System designed to work with, and how does this integration affect its use in a clinical setting?

  The OPUS CEA Test System is specifically designed for integration with the OPUS Plus and OPUS Magnum analyzers, as explicitly approved in its regulatory submission. This means it is intended to be used exclusively on these platforms to measure carcinoembryonic antigen (CEA) levels in serum or plasma. Clinicians must ensure the system is compatible with their analyzer model to avoid operational errors, as the test system is not interchangeable with other devices outside these two platforms.

• Is the OPUS CEA Test System intended for single-use or reusable applications, and how does this impact its handling in a laboratory?

  The OPUS CEA Test System is described as a reusable diagnostic tool, but it is supplied sterile and intended for single-use *per test cycle*. This means each test run requires a fresh application or preparation of the system components, even though the core device itself may be reused across multiple test cycles. Laboratories must follow sterile handling protocols to maintain accuracy and prevent cross-contamination between tests.

• What types of biological samples can the OPUS CEA Test System analyze, and why is this specification important for clinical workflows?

  The OPUS CEA Test System is designed for the quantitative measurement of carcinoembryonic antigen (CEA) in *serum or plasma* samples. This specificity is critical for clinical workflows because it ensures compatibility with standard blood collection methods, allowing laboratories to use either whole-blood derivatives (serum) or anticoagulated samples (plasma) without modification. This flexibility supports routine monitoring of patients with suspected or confirmed colorectal, gastric, or pancreatic malignancies.

• How should the OPUS CEA Test System be stored, and are there any special considerations for maintaining its performance or sterility?

  While the device data does not specify storage conditions explicitly, the system is supplied *sterile* and intended for single-use per test cycle, implying it should be stored in a clean, dry environment to preserve sterility and functionality. Laboratories should follow manufacturer guidelines (likely included in accompanying documentation) to avoid contamination or degradation, particularly if the system is reused across multiple test cycles. Proper storage ensures reliable performance and compliance with immunology testing protocols.