CEA-Roche Test Kit

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

Generic Name

SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

PMA Number

P800063 ↗

FDA Product Code

DHX

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

APPR Approved

PMA Supplement

S002

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• What clinical conditions is the CEA-Roche Test Kit primarily used to monitor or diagnose, and how does it help in patient management?

  The CEA-Roche Test Kit is designed for the qualitative and quantitative detection of carcinoembryonic antigen (CEA) in human serum or plasma, a tumor marker linked to cancers such as colorectal, gastric, pancreatic, and lung malignancies. It aids clinicians in assessing disease progression, recurrence, or response to treatment in patients with known cancer by providing measurable levels of CEA, helping guide treatment decisions and monitor therapeutic effectiveness.

• Is the CEA-Roche Test Kit intended for single-use only, and if so, what does this mean for clinical workflows?

  Yes, the CEA-Roche Test Kit is explicitly intended for single-use. This means each kit is designed for one test procedure and should not be reused, ensuring accuracy and preventing cross-contamination. Clinicians must adhere to manufacturer instructions for proper handling and disposal to maintain test integrity and comply with safety protocols.

• How is the CEA-Roche Test Kit supplied, and are there any special storage requirements mentioned in the available data?

  The CEA-Roche Test Kit is supplied as a reagent kit for in vitro diagnostic use in clinical laboratories. While the data does not specify exact storage conditions (such as temperature or humidity), proper handling and storage are critical to preserve the kit’s performance. Laboratories should follow the manufacturer’s guidelines to ensure reagents remain stable and effective for their intended use.

• What regulatory pathway was followed for the CEA-Roche Test Kit, and what does this mean for its use in clinical settings?

  The CEA-Roche Test Kit was authorized under the FDA’s Premarket Approval (PMA) pathway, with PMA number P800063 and supplement S003. This classification (Class II) and regulatory route indicate that the device underwent rigorous review by the FDA’s Immunology (IM) advisory committee to ensure safety and effectiveness. Clinicians can rely on this approval as evidence of the kit’s validated performance for detecting CEA in serum or plasma.

• Are there multiple versions or models of the CEA-Roche Test Kit, and if so, how can a clinician determine which one to use?

  The data lists multiple FEI numbers (e.g., 2517506, 3007111389) and registration numbers, which may correspond to different kit versions or lot-specific identifiers. However, these are administrative identifiers rather than distinct clinical models. Clinicians should refer to the manufacturer’s documentation or consult with Roche’s technical support to confirm compatibility with their laboratory systems or specific testing protocols, ensuring the correct kit is selected for accurate CEA detection.