Digitoxin (FPIA) Kit
by Tudor Laboratories, Inc. 510(k)
Active
510(k) K913240
Overview
The Digitoxin (FPIA) Kit is an enzyme immunoassay device designed for the quantitative measurement of digitoxin in biological samples. It employs fluorescence polarization immunoassay (FPIA) technology to detect and quantify low concentrations of digitoxin, a cardiac glycoside used in clinical toxicology assessments. This kit provides a rapid and sensitive method for monitoring digitoxin levels, aiding in the management of patients with potential toxicity or therapeutic drug monitoring needs.
This kit is supplied as a diagnostic reagent intended for use in clinical laboratory settings. It is classified as a Class II device under FDA regulations and has received 510(k) clearance (K913240) as substantially equivalent to a predicate device. The kit is not described as single-use or reusable in the provided data, though standard laboratory immunoassay practices typically require single-use components. No specific sterility or MRI safety information is provided, and storage conditions are not detailed beyond typical reagent storage guidelines. The product code LFM is associated with its regulatory filing.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913240 | Date6 Sep 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LFM
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3300
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Tudor Laboratories, Inc.
Questions
What is the Digitoxin (FPIA) Kit used for?
The Digitoxin (FPIA) Kit is designed for the quantitative measurement of digitoxin in biological samples, specifically for clinical toxicology assessments. It helps clinicians monitor digitoxin levels in patients to manage potential toxicity or ensure therapeutic drug monitoring, ensuring safe and effective treatment with this cardiac glycoside.
How is the Digitoxin (FPIA) Kit supplied and intended for use?
This kit is supplied as a diagnostic reagent intended exclusively for use in clinical laboratory settings. It employs fluorescence polarization immunoassay (FPIA) technology to detect and quantify low concentrations of digitoxin, providing rapid and sensitive results. Standard laboratory practices typically require single-use components for immunoassay kits, though this is not explicitly stated in the product details.
Is the Digitoxin (FPIA) Kit sterile?
The provided data does not specify whether the Digitoxin (FPIA) Kit is sterile or not. For clinical use, it is generally recommended to follow standard laboratory protocols for reagent sterility, particularly when handling biological samples. Always refer to the manufacturer’s instructions for proper handling and storage.
What regulatory approval does the Digitoxin (FPIA) Kit hold?
The Digitoxin (FPIA) Kit has received FDA 510(k) clearance (K913240) and is classified as a Class II device under FDA regulations. This clearance indicates it is substantially equivalent to a predicate device, ensuring it meets regulatory standards for safety and effectiveness in clinical toxicology applications.
What storage conditions should be followed for the Digitoxin (FPIA) Kit?
The product data does not provide specific storage conditions beyond typical reagent storage guidelines. Generally, immunoassay kits like this should be stored in a cool, dry place, protected from light and extreme temperatures. Always consult the manufacturer’s instructions or packaging for precise storage recommendations to maintain kit integrity and performance.