TDXR Flecainide
by Abbott Laboratories 510(k)
Active
510(k) K872175
Overview
The TDXR Flecainide is an enzyme immunoassay device used for the quantitative measurement of flecainide acetate in serum or plasma. Flecainide is a class IC antiarrhythmic drug, and its serum concentration monitoring is critical in managing cardiac arrhythmias to ensure therapeutic efficacy and minimize toxicity. This assay provides clinical toxicology laboratories with a reliable method for determining drug levels in patient samples, aiding in the assessment of drug therapy effectiveness and potential adverse effects.
The TDXR Flecainide is supplied as a reagent kit for use on the TDX system, a random-access immunoassay analyzer. It is intended for in vitro diagnostic use in clinical toxicology settings, such as hospitals and reference laboratories. The device is classified under FDA regulation 862.3320 and carries a product code LBZ, with a 510(k) clearance (K872175) issued in 1987. No sterility or single-use specifications are explicitly stated in the regulatory data, but it is designed for laboratory use under controlled conditions to ensure accurate and reproducible results.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872175 | Date13 Aug 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LBZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3320
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the TDXR Flecainide assay used for?
The TDXR Flecainide assay is an enzyme immunoassay designed to measure flecainide acetate concentrations in serum or plasma. Flecainide is a class IC antiarrhythmic drug, and monitoring its levels helps clinicians balance therapeutic efficacy with toxicity risk in patients with cardiac arrhythmias. This assay supports clinical toxicology labs by providing reliable drug-level data to optimize treatment and reduce adverse effects.
How is the TDXR Flecainide supplied, and what system does it require?
The TDXR Flecainide is supplied as a reagent kit specifically for use on the TDX immunoassay analyzer, a random-access system. This integration ensures compatibility with the analyzer’s workflow, enabling automated quantitative measurements of flecainide in patient samples. The kit must be used within the controlled environment of a clinical toxicology lab.
Is the TDXR Flecainide assay single-use or reusable, and what about sterility?
The regulatory data does not explicitly state whether the TDXR Flecainide assay components are single-use or reusable. However, as a reagent kit for laboratory use, it is designed to be handled under controlled conditions to maintain accuracy and reproducibility. Sterility specifications are not detailed, but proper laboratory protocols should govern handling to ensure reliable assay performance.
What regulatory pathway does the TDXR Flecainide follow, and what is its classification?
The TDXR Flecainide received FDA clearance via a 510(k) submission (K872175) under the Traditional clearance type, filed in 1987. It is classified under FDA regulation 862.3320 and falls under the product code LBZ, with a decision code of SESE (Substantially Equivalent). The device is intended for in vitro diagnostic use in clinical toxicology, reviewed by the Clinical Toxicology Advisory Committee.
Can this assay be used in any clinical setting, or is it limited to specific environments?
The TDXR Flecainide assay is intended for use in clinical toxicology settings, such as hospitals and reference laboratories equipped with the TDX analyzer. Its design assumes controlled laboratory conditions to ensure precise and reproducible measurements of flecainide levels. Point-of-care or non-laboratory settings lack the necessary infrastructure for this immunoassay.