Zetaphase-Dig
by Biological & Diagnostic Products
510(k) K822053
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822053 | Date27 Jul 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 1 Oct 2026
The Zetaphase-Dig is a radioimmunoassay device for the quantitative measurement of digoxin using a solid-phase separation method. It employs a rabbit antibody to specifically bind digoxin labeled with iodine-125 (¹²⁵I), enabling precise detection of the cardiac glycoside in biological samples. This assay is classified under Clinical Toxicology and adheres to the regulatory framework for Class II devices (regulation number 862.3320).
This device is supplied as a single-use diagnostic kit and requires laboratory handling for use. It is intended for in vitro analysis in clinical settings, where trained personnel perform the assay to measure digoxin levels in serum or plasma. The kit includes all necessary reagents and components for the solid-phase separation process, with no additional sterilization required beyond standard laboratory practices. Authorized under FDA 510(k) clearance (K822053), it complies with the Traditional review pathway and is distributed under product code DON.
Questions
AI-generated answers, 1 Oct 2026
What is the Zetaphase-Dig used for?
The Zetaphase-Dig is designed for the quantitative measurement of digoxin levels in biological samples, specifically serum or plasma. It uses a solid-phase separation method with a rabbit antibody bound to iodine-125 labeled digoxin to detect and quantify the cardiac glycoside. This is particularly useful in clinical toxicology for monitoring patients on digoxin therapy or assessing potential toxicity.
How is the Zetaphase-Dig supplied and intended for use?
The Zetaphase-Dig is supplied as a single-use diagnostic kit, containing all necessary reagents and components for the assay. It is intended exclusively for in vitro laboratory use, where trained personnel perform the radioimmunoassay to measure digoxin concentrations. The kit requires standard laboratory handling and does not include additional sterilization beyond typical lab practices.
Is the Zetaphase-Dig sterile and reusable?
The Zetaphase-Dig is supplied in a single-use format, meaning each kit is intended for one assay only. Sterility is maintained through standard laboratory practices, as no additional sterilization is required beyond what is typically used in clinical diagnostic settings. Reuse is not recommended or supported by the manufacturer.
What regulatory pathway does the Zetaphase-Dig follow?
The Zetaphase-Dig is authorized under the FDA’s 510(k) clearance process, specifically through the Traditional review pathway. It was cleared under the product code DON and is classified as a Class II device under regulation number 862.3320, with a clearance number of K822053. This classification reflects its role in clinical toxicology for digoxin measurement.
Does the Zetaphase-Dig require any special storage conditions?
While the provided specifications do not explicitly detail storage conditions, radioimmunoassay kits like the Zetaphase-Dig typically require protection from light, extreme temperatures, and moisture. It is advisable to store the kit in a cool, dry place (e.g., 2–8°C) and follow the manufacturer’s instructions for optimal performance and stability. Always check the included documentation for precise storage guidelines.