Abbott Axsym AFP Kit
by Abbott Laboratories PMA
Active
PMA P820060
Overview
The Abbott Axsym AFP Kit is an In Vitro Diagnostic (IVD) immunoassay test kit designed for the quantitative measurement of alpha-fetoprotein (AFP) in serum or plasma. AFP is a biomarker used primarily in screening for neural tube defects in prenatal diagnostics and as a tumor marker in certain cancers, including hepatocellular carcinoma and germ cell tumors. This device falls under the classification of a Kit, Test, Alpha-Fetoprotein for Neural Tube Defects, as defined by regulatory nomenclature authorities.
The kit is intended for use in clinical laboratories and is supplied as a single-use diagnostic reagent system requiring manual handling. It operates via enzyme immunoassay (EIA) technology and is authorized under FDA_PMA (Premarket Approval) with PMA number P820060. The device is not intended for MRI environments, and sterility is maintained through terminal sterilization or aseptic processing as part of its manufacturing specifications. Storage conditions are not specified in the data but are typically controlled (e.g., refrigerated or room temperature) to preserve reagent stability.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP820060 | Date31 Aug 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
-
- Terminated Z-0299-2008
The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. product. The assay labeling indicates that the limit flag should be set no lower than 20 ng/mL
-
- Terminated Z-0726-03
The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values
Specification
- Full name
- Abbott Axsym Afp
- Trade Name
- Abbott Afp-Eia Diagnostic Kit for Cancer
- Generic Name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- PMA Number
- FDA Product Code
- LOJ
- Regulation
- 21 CFR Part 866.6010
- Advisory Committee
- Immunology
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Other devices from Abbott Laboratories
Questions
What clinical applications is the Abbott Axsym AFP Kit primarily used for, and how does it work?
The Abbott Axsym AFP Kit is primarily used for quantitative measurement of alpha-fetoprotein (AFP) in serum or plasma to screen for neural tube defects in prenatal diagnostics and as a tumor marker for certain cancers, such as hepatocellular carcinoma and germ cell tumors. It operates via enzyme immunoassay (EIA) technology, which detects and quantifies AFP levels through a manual, single-use reagent system.
Is this device single-use, and if so, what does that mean for clinical workflows?
Yes, the Abbott Axsym AFP Kit is designed for single-use only. This means each kit is intended for one test procedure and cannot be reused, ensuring accuracy and sterility for each patient sample. Clinicians must prepare a new kit for each measurement, which helps maintain consistency and reliability in diagnostic results.
How should the Abbott Axsym AFP Kit be stored, and what precautions should be taken?
While specific storage conditions aren’t detailed in the provided data, diagnostic reagent kits like this typically require controlled storage—such as refrigeration or room temperature—to preserve reagent stability. It’s important to follow the manufacturer’s instructions (likely included in the kit documentation) to avoid degradation, as improper storage could compromise test accuracy.
What regulatory pathway was followed for this device, and what does that imply about its validation?
The Abbott Axsym AFP Kit was authorized under the FDA’s Premarket Approval (PMA) pathway, indicated by PMA number P820060. This pathway is reserved for higher-risk medical devices, implying that the kit underwent rigorous clinical trials and validation to demonstrate safety and effectiveness before approval. The PMA process ensures that the device meets stringent regulatory standards.
Can this kit be used in any clinical setting, or are there specific limitations to its use?
The kit is intended exclusively for use in clinical laboratories and requires manual handling, so it is not designed for point-of-care or home-use settings. Additionally, it is explicitly not intended for use in MRI environments, which may limit its applicability in certain diagnostic workflows where imaging compatibility is a concern.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA PMA P820060