CEA-RIA Diagnostic Test Kit
by Abbott Laboratories PMA
Active
PMA P800005
Overview
This device is a Radioimmunoassay (RIA) System for Carcinoembryonic Antigen (CEA), designed to quantitatively measure CEA levels in serum or plasma. It employs a goat-derived antibody to detect CEA, a tumor marker associated with certain cancers, including colorectal, pancreatic, and lung malignancies. The assay provides a sensitive method for monitoring disease progression or response to treatment in clinical settings.
The CEA-RIA Diagnostic Test Kit is supplied as a single-use in vitro diagnostic reagent and requires laboratory processing. It is intended for use in regulated clinical immunology settings and must be handled according to manufacturer instructions for sterility and stability. The kit is authorized under FDA_PMA (P800005) and classified as a Class II device (regulation number 866.6010). Storage conditions and expiration dates are specified in the accompanying documentation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP800005 | Date29 Mar 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Anti-Carcinoembryonic Antigen (Goat) Cea Ria
- Generic Name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- PMA Number
- FDA Product Code
- DHX
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.6010
- Advisory Committee
- Immunology
- FDA Decision
- APPR Approved
- PMA Supplement
- S004
Other devices from Abbott Laboratories
Questions
What clinical conditions is this CEA-RIA test primarily used to monitor in patients?
This test is designed to quantitatively measure carcinoembryonic antigen (CEA) levels in serum or plasma, which is a tumor marker linked to certain cancers. Clinically, it is used to monitor disease progression or response to treatment in patients with colorectal, pancreatic, or lung malignancies, where elevated CEA levels may indicate tumor activity or recurrence.
Is this CEA-RIA Diagnostic Test Kit intended for single-use or repeated use in a laboratory setting?
The CEA-RIA Diagnostic Test Kit is explicitly supplied as a single-use in vitro diagnostic reagent. It requires laboratory processing and must be handled according to manufacturer instructions to ensure sterility and stability, meaning each kit is designed for one-time use per assay.
What regulatory pathway was followed for this device’s approval, and what class does it fall under?
This device was authorized under the FDA’s Premarket Approval (PMA) pathway with the approval number P800005. It is classified as a Class II medical device under regulation number 866.6010, indicating it poses moderate risk and requires special controls to ensure safety and effectiveness.
How should the CEA-RIA Diagnostic Test Kit be stored, and where can I find expiration details?
Storage conditions and expiration dates for the CEA-RIA Diagnostic Test Kit are detailed in the accompanying manufacturer documentation. Since it is a single-use reagent, proper storage is critical to maintaining its performance—check the packaging or instructions for specific temperature and handling requirements.
Does this test require specialized laboratory equipment or training to perform?
Yes, this test is intended for use in regulated clinical immunology settings, meaning it requires laboratory processing and personnel trained in radioimmunoassay (RIA) techniques. The kit itself is designed for use with standard laboratory equipment, but proper handling, sterility protocols, and adherence to manufacturer instructions are essential for accurate results.