Digoxin Riabead Diagnostic Kit
by Abbott Laboratories 510(k)
Active
510(k) K803075
Overview
The Digoxin Riabead Diagnostic Kit is a radioimmunoassay device designed for the quantitative measurement of digoxin in serum or plasma. It employs a solid-phase separation technique using rabbit antibody to detect radiolabeled digoxin (125-I), enabling precise clinical toxicology assessments. This in vitro diagnostic tool supports monitoring of digoxin levels in patients, particularly those undergoing cardiac therapy.
The kit is supplied as a single-use diagnostic reagent and requires laboratory handling. It is classified under FDA regulation 862.3320 and falls under Device Class II, with clearance via a 510(k) submission (K803075) filed under the Clinical Toxicology advisory committee. Sterility and performance are validated for clinical use, though MRI safety and reusable components are not applicable. Storage conditions and shelf life are specified in accompanying documentation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK803075 | Date22 Dec 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DON
- 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 Digoxin Riabead Diagnostic Kit used for?
The Digoxin Riabead Diagnostic Kit is designed for the quantitative measurement of digoxin levels in serum or plasma. It uses a solid-phase radioimmunoassay technique with rabbit antibody to detect radiolabeled digoxin (125-I), enabling precise clinical toxicology assessments. This is particularly useful for monitoring digoxin concentrations in patients receiving cardiac therapy, helping clinicians adjust dosages to avoid toxicity or under-treatment.
How is the Digoxin Riabead Diagnostic Kit supplied and intended for use?
The kit is supplied as a single-use diagnostic reagent, meaning each kit is intended for one-time laboratory use only. It requires handling in a controlled laboratory setting to perform the radioimmunoassay. The design ensures sterility and performance validation for clinical use, but it is not intended for use outside of professional diagnostic laboratories.
Is the Digoxin Riabead Diagnostic Kit sterile and reusable?
The kit is validated for sterility and is intended for single-use only. It is not designed for reuse or reprocessing. Sterility is maintained through proper packaging and handling as outlined in the accompanying documentation, ensuring reliable performance for one diagnostic test per kit.
What storage conditions and shelf life apply to the Digoxin Riabead Diagnostic Kit?
Storage conditions and shelf life details are specified in the accompanying documentation provided with the kit. These instructions are critical to maintaining the integrity of the reagents, ensuring accurate test results. Always refer to the documentation for precise storage requirements, such as temperature ranges and expiration dates.
What regulatory pathway does the Digoxin Riabead Diagnostic Kit follow?
The Digoxin Riabead Diagnostic Kit follows the FDA’s 510(k) clearance pathway, specifically under the Clinical Toxicology advisory committee. It was cleared via a traditional 510(k) submission (K803075) and is classified under FDA regulation 862.3320 as a Class II device. This classification indicates that it has been determined to be substantially equivalent to a predicate device already on the market.