AxSYM Methadone
by Abbott Laboratories 510(k)
Active
510(k) K953499
Overview
The AxSYM Methadone is an enzyme immunoassay device designed for the qualitative detection of methadone in biological specimens. As classified under the nomenclature for enzyme immunoassays, it quantifies methadone concentrations by leveraging immunochemical reactions to measure antigen-antibody interactions, enabling rapid and sensitive analysis in clinical toxicology settings.
This device is intended for single-use in laboratory environments and requires no sterilization beyond manufacturer-provided packaging. It operates within Class II regulatory classification under FDA regulation 862.3620 and holds a 510(k) clearance (K953499) for substantial equivalence in clinical toxicology applications. Supplied as a ready-to-use assay, it adheres to standard laboratory protocols and does not require MRI compatibility considerations. Storage follows manufacturer guidelines to preserve assay integrity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK953499 | Date13 Nov 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DJR
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3620
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the AxSYM Methadone device used for?
The AxSYM Methadone is an enzyme immunoassay device designed for the qualitative detection and quantification of methadone concentrations in biological specimens. It leverages immunochemical reactions to measure antigen-antibody interactions, making it useful in clinical toxicology settings to assess methadone presence or levels in patient samples.
How is the AxSYM Methadone device supplied and prepared for use?
The AxSYM Methadone is supplied as a ready-to-use assay, meaning no additional preparation is required beyond unpacking the device. It is intended for single-use in laboratory environments and comes pre-packaged, eliminating the need for sterilization beyond what the manufacturer provides.
Is the AxSYM Methadone device sterile and reusable?
The device is not intended to be reused. It is designed for single-use only and is supplied in manufacturer-provided packaging that ensures sterility and integrity for one use. No additional sterilization is required before use.
What regulatory clearance does the AxSYM Methadone device hold?
The AxSYM Methadone holds a 510(k) clearance (K953499) from the FDA, demonstrating substantial equivalence in clinical toxicology applications. It is classified under FDA regulation 862.3620 as an enzyme immunoassay device.
How should the AxSYM Methadone device be stored to maintain its integrity?
Storage of the AxSYM Methadone device follows the manufacturer’s guidelines to preserve assay integrity. These guidelines typically include maintaining appropriate temperature conditions, avoiding exposure to light, and ensuring the packaging remains unopened until use. Always refer to the manufacturer’s instructions for specific storage details.