AxSYM B12
by Abbott Laboratories 510(k)
Active
510(k) K965186
Overview
The AxSYM B12 is a radioassay device for measuring vitamin B12 levels in human serum or plasma. It employs a microparticle enzyme intrinsic factor assay to provide quantitative results, enabling clinical assessment of vitamin B12 deficiency or excess.
This device is intended for use on the AxSYM System and is classified as a Class II medical device under FDA regulations (product code CDD). It is supplied as a single-use assay kit, requiring no sterilization beyond manufacturer-provided packaging. The AxSYM B12 received FDA 510(k) clearance (K965186) in 1997, demonstrating substantial equivalence to a predecessor product. Storage and handling follow standard laboratory protocols for immunoassay reagents.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK965186 | Date24 Mar 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CDD
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1810
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What clinical conditions can the AxSYM B12 assay help assess?
The AxSYM B12 assay quantifies vitamin B12 levels in human serum or plasma, enabling clinicians to evaluate vitamin B12 deficiency or excess. This is particularly useful in diagnosing conditions like pernicious anemia, megaloblastic anemia, or neurological disorders linked to B12 insufficiency. The microparticle enzyme intrinsic factor assay provides precise results to support clinical decision-making.
How is the AxSYM B12 assay supplied, and does it require sterilization?
The AxSYM B12 is supplied as a single-use assay kit, fully contained within manufacturer-provided packaging. No additional sterilization is required beyond the sterile barrier of the original packaging, as it is designed for one-time use only. This ensures consistency and safety for each test.
Can this assay be used with other systems besides the AxSYM System?
No, the AxSYM B12 assay is specifically intended for use exclusively on the AxSYM System. It is not compatible with other immunoassay platforms or systems, as its design and calibration are tailored to the AxSYM’s operational parameters and workflow.
What storage and handling precautions should be followed for the AxSYM B12 assay?
The AxSYM B12 assay should be stored and handled according to standard laboratory protocols for immunoassay reagents. This includes maintaining the kit in its original packaging, protecting it from extreme temperatures, light, and contamination, and adhering to manufacturer guidelines for shelf life and expiration dates. Improper storage may compromise assay accuracy or reliability.
Is the AxSYM B12 assay reusable, or is it designed for single-use only?
The AxSYM B12 assay is explicitly designed for single-use only. Each kit is intended for one test cycle, after which it should be discarded. This design ensures consistency in results, reduces the risk of cross-contamination, and aligns with best practices for immunoassay testing to maintain precision and patient safety.