Tandem(R)-R Carcinoembryonic Antigen Assay

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

PMA Number

P840019 ↗

FDA Product Code

DHX

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

APPR Approved

PMA Supplement

S003

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See all devices from Hybritech, Inc. →

• What clinical specialty is the Tandem-R Carcinoembryonic Antigen Assay primarily used in, and how does it assist in patient care?

  The Tandem-R Carcinoembryonic Antigen Assay is designed for use in clinical immunology, particularly for monitoring patients with colorectal cancer and other malignancies. It quantifies carcinoembryonic antigen (CEA) levels in human serum or plasma using immunometric techniques, aiding clinicians in diagnosing cancer, assessing treatment response, and tracking disease progression. Elevated CEA levels can indicate tumor presence or recurrence, making this assay valuable for evidence-based decision-making in oncology.

• Is this assay intended for single-use or repeated testing, and how should it be handled in a laboratory setting?

  The Tandem-R Carcinoembryonic Antigen Assay is intended for single-use only in clinical immunology laboratories. As a reagent kit, it must be used once per test to ensure accuracy and reliability. While specific storage conditions aren’t detailed, standard protocols for in vitro diagnostic devices should be followed—including protection from extreme temperatures, light, and contamination—to maintain assay integrity. Always refer to the manufacturer’s instructions for precise handling.

• What regulatory pathway was followed for FDA clearance of this device, and what does the PMA number indicate?

  The Tandem-R Carcinoembryonic Antigen Assay received FDA clearance through a Premarket Approval (PMA) process, as indicated by the PMA number P840019. This pathway is used for higher-risk medical devices, including in vitro diagnostics like this assay, to ensure safety and effectiveness before market authorization. The PMA number serves as a unique identifier for this specific submission and approval record.

• Are there multiple versions or models of this assay, and how can I verify compatibility with my laboratory’s systems?

  The assay is listed under multiple FEI numbers (e.g., 2517506, 2432235, etc.) and registration numbers, which may reflect different lot batches, supplements, or minor updates (e.g., supplement S001) rather than distinct models. To confirm compatibility, check the product code (DHX) and consult the manufacturer’s documentation or your laboratory’s existing systems for supported assay versions. Hybritech, Inc. (now part of Siemens Healthineers) would provide guidance on integration with automated platforms if applicable.