TDX Amphetamine/Methamphetamine II
by Abbott Laboratories 510(k)
Active
510(k) K883707
Overview
The TDX Amphetamine/Methamphetamine II is an enzyme immunoassay device designed for the qualitative detection of amphetamine and methamphetamine in urine specimens. It falls under the category of clinical toxicology assays, providing rapid results to aid in identifying illicit drug use or monitoring therapeutic drug levels in clinical settings.
This device is intended for single-use in laboratory settings and requires no sterilization beyond standard laboratory practices. It is compatible with the TDX System and operates as a reagent cartridge within the instrument. The device is classified as Class II under FDA regulations and holds a 510(k) clearance (K883707) for substantial equivalence in clinical toxicology applications. Storage and handling follow manufacturer guidelines for reagent stability and instrument compatibility.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883707 | Date20 Oct 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DKZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3100
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What clinical setting is the TDX Amphetamine/Methamphetamine II designed for, and how does it help healthcare providers?
The TDX Amphetamine/Methamphetamine II is designed for use in laboratory settings to perform qualitative detection of amphetamine and methamphetamine in urine specimens. It aids healthcare providers by offering rapid results to help identify illicit drug use or monitor therapeutic drug levels, supporting clinical toxicology applications.
Is the TDX Amphetamine/Methamphetamine II intended for single-use or reusable applications, and what are the handling requirements?
The device is intended for single-use only in laboratory settings. No additional sterilization beyond standard laboratory practices is required, as it is supplied as a reagent cartridge designed exclusively for use within the TDX System. Proper handling follows manufacturer guidelines to ensure reagent stability and instrument compatibility.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The TDX Amphetamine/Methamphetamine II received FDA clearance through a 510(k) submission (K883707), classified under substantial equivalence (SESE) in the category of clinical toxicology assays. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for its intended use in detecting amphetamine and methamphetamine in urine.
How is the TDX Amphetamine/Methamphetamine II supplied, and what system does it require for operation?
The device is supplied as a reagent cartridge and is compatible only with the TDX System. It is not a standalone test but functions as an integral component of the instrument, requiring proper integration with the TDX platform for accurate qualitative detection of amphetamine and methamphetamine in urine samples.