Optimate Digoxin Test
by Miles Laboratories, Inc. 510(k)
Active
510(k) K853021
Overview
The Optimate Digoxin Test is a radioimmunoassay device designed for the quantitative measurement of digoxin in serum or plasma. It employs a rabbit antibody and charcoal separation to detect levels of the cardiac glycoside, aiding in clinical toxicology assessments and therapeutic monitoring of patients receiving digoxin therapy.
This in vitro diagnostic device is supplied as a single-use kit and requires regulatory compliance under FDA 510(k) clearance (K853021). It falls under product code DPB, classified as a Class II device under regulation 862.3320, and is intended for use in clinical laboratory settings. Sterility and proper storage conditions are critical to maintain assay accuracy.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853021 | Date7 Aug 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DPB
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3320
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Miles Laboratories, Inc.
Questions
What is the Optimate Digoxin Test used for?
The Optimate Digoxin Test is designed for the quantitative measurement of digoxin levels in serum or plasma. Digoxin is a cardiac glycoside used in heart therapy, and accurate measurement helps clinicians assess toxicity risks and optimize patient dosing. This is particularly important in clinical toxicology and therapeutic monitoring to prevent overdoses or underdoses.
How is the Optimate Digoxin Test supplied, and is it single-use?
The Optimate Digoxin Test is supplied as a single-use kit, meaning each kit is intended for one assay procedure only. This ensures sterility and consistency in results, as reuse could compromise accuracy or introduce contamination. The kit’s design aligns with standard radioimmunoassay practices to maintain reliability in clinical laboratory settings.
What sterility and storage requirements apply to this device?
Sterility is critical for the Optimate Digoxin Test, as it is an in vitro diagnostic device used in sensitive clinical applications. The kit must be stored under conditions that preserve its integrity, typically at controlled room temperature (15–30°C) and protected from moisture or extreme light. Proper storage prevents degradation of the rabbit antibody and charcoal separation components, which are essential for accurate digoxin detection.
Is this device reusable, or is it intended for single-use only?
The Optimate Digoxin Test is explicitly designed for single-use only. Radioimmunoassay kits like this rely on precise, uncontaminated reagents to deliver accurate results. Reuse could introduce errors, cross-contamination, or compromise the stability of the rabbit antibody or radioactive tracer, leading to unreliable measurements. Single-use aligns with best practices for diagnostic safety and consistency.
What regulatory pathway does this device follow, and where is it classified?
The Optimate Digoxin Test follows the FDA’s 510(k) clearance pathway, with a decision labeled as ‘Substantially Equivalent’ under classification DPB. It is categorized as a Class II device under regulation 862.3320, indicating moderate regulatory oversight due to its role in clinical toxicology and therapeutic monitoring. This classification ensures compliance with stringent performance standards for in vitro diagnostics.