CEA-EIA Diagnostic Test Kit
by Abbott Laboratories PMA
Active
PMA P800056
Overview
This device is a System, Test, Carcinoembryonic Antigen (CEA), classified as a Class II diagnostic immunoassay. It is designed to quantitatively measure carcinoembryonic antigen (CEA) levels in serum or plasma, aiding in the monitoring of certain cancers, including colorectal, pancreatic, and lung malignancies, as well as benign conditions like inflammatory bowel disease.
The CEA-EIA Diagnostic Test Kit is intended for in vitro use in clinical laboratories. Supplied as a single-use reagent kit, it requires no sterilization beyond manufacturer-provided packaging. The test adheres to FDA-authorized Premarket Approval (PMA P800056) and is regulated under 21 CFR 866.6010, with supplementary updates (S002). Compliance with immunology standards ensures accurate detection within specified assay ranges, though MRI safety, reusable components, or alternative storage conditions are not applicable.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP800056 | Date11 Mar 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Cea--Ria Dixgnostic Test Kit
- Generic Name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- PMA Number
- FDA Product Code
- DHX
- Regulation
- 21 CFR Part 866.6010
- Advisory Committee
- Immunology
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Other devices from Abbott Laboratories
Questions
What is the CEA-EIA Diagnostic Test Kit used for in clinical settings?
The CEA-EIA Diagnostic Test Kit is designed to quantitatively measure carcinoembryonic antigen (CEA) levels in serum or plasma. It aids in monitoring patients with certain cancers—such as colorectal, pancreatic, and lung malignancies—as well as benign conditions like inflammatory bowel disease. The test is intended for in vitro use in clinical laboratories to support diagnostic or follow-up assessments.
Is the CEA-EIA Diagnostic Test Kit single-use or reusable, and how should it be handled?
The CEA-EIA Diagnostic Test Kit is supplied as a single-use reagent kit, meaning each kit is intended for one test procedure only. No additional sterilization is required beyond the manufacturer-provided packaging, as it is designed for one-time use in controlled laboratory environments.
What regulatory pathway does the CEA-EIA Diagnostic Test Kit follow, and where is it authorized?
The CEA-EIA Diagnostic Test Kit is authorized under the FDA Premarket Approval (PMA) pathway, with the approval number P800056 and a supplementary update (S002). It is regulated under 21 CFR 866.6010 and is classified as a Class II diagnostic immunoassay, ensuring compliance with immunology standards for accurate CEA detection.
Are there different sizes or models of the CEA-EIA Diagnostic Test Kit, or is it available in a single configuration?
The data provided lists multiple FEI numbers and registration numbers, which typically correspond to different lot or batch identifiers rather than distinct sizes or models. The kit itself is standardized for quantitative CEA measurement in serum/plasma, but variations in registration numbers may reflect different manufacturing batches or minor updates under the same PMA approval.
How should the CEA-EIA Diagnostic Test Kit be stored, and are there any special handling requirements?
The CEA-EIA Diagnostic Test Kit is supplied in manufacturer-provided packaging designed to maintain integrity until use. Since it is a single-use reagent kit, storage should follow the manufacturer’s instructions (not provided in the data), which likely include protection from extreme temperatures, light, or contamination. No special storage conditions (e.g., refrigeration for reuse) are mentioned, as the kit is intended for one-time use in clinical laboratories.