Enzymun Test CEA

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

Full name

Enzymun Test{r} Cea

Generic Name

SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

PMA Number

P860058 ↗

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)

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• What is the Enzymun Test CEA used for in clinical practice, and how does it differ from other tumor markers?

  The Enzymun Test CEA is an immunoassay designed specifically for the quantitative measurement of carcinoembryonic antigen (CEA) in human serum or plasma. CEA is primarily used as a tumor marker to monitor colorectal cancer progression, recurrence, or response to treatment, though it may also be elevated in other malignancies or non-malignant conditions like inflammation or smoking. Unlike broader tumor markers, CEA is particularly relevant for colorectal cancer surveillance due to its clinical correlation with this malignancy.

• How is the Enzymun Test CEA supplied, and what storage conditions are required to maintain its stability?

  The Enzymun Test CEA is supplied as a reagent kit intended for manual use in clinical laboratories. It must be stored under refrigeration between 2–8°C to preserve stability and ensure accurate results. The single-use nature of the kit emphasizes the importance of proper storage to prevent degradation before use.

• Is the Enzymun Test CEA sterile, and if so, how is sterility ensured during manufacturing?

  Yes, the Enzymun Test CEA is sterile, as confirmed through validated manufacturing processes. Sterility is a critical aspect of immunoassay reagents to prevent contamination and ensure reliable test results, particularly in clinical laboratory settings where precision is essential.

• What regulatory pathway was followed for the approval of the Enzymun Test CEA, and what does the PMA designation indicate?

  The Enzymun Test CEA received a Premarket Approval (PMA) designation (P860058) from the FDA, which is the highest level of device approval required for Class II medical devices. This designation indicates that the device underwent rigorous review by the FDA to ensure its safety and effectiveness for its intended use as a quantitative immunoassay for CEA in serum or plasma. The PMA also includes supplementary updates (e.g., S001) reflecting modifications to design, components, or specifications.

• Are there multiple versions or models of the Enzymun Test CEA, and how can I identify the correct kit for my laboratory?

  Yes, the Enzymun Test CEA includes multiple FEI numbers (e.g., 3012963943, 3002809144) and registration numbers, which correspond to different kit versions or lot-specific identifiers. These identifiers are typically listed on the packaging or documentation provided by Boehringer Mannheim Corp. To ensure compatibility, verify the specific FEI or registration number against your laboratory’s existing inventory or consult the manufacturer’s instructions to confirm the correct kit for your workflow.