Ames TDA Disopyramide Test
by Miles Laboratories, Inc. 510(k)
Active
510(k) K832766
Overview
The Ames TDA Disopyramide Test is an enzyme immunoassay designed for the qualitative detection of disopyramide in biological specimens. It falls under the category of clinical toxicology assays, enabling the identification of disopyramide levels in patient samples to aid in therapeutic monitoring or poisoning investigations.
This test is supplied as a diagnostic kit for in vitro use, intended for single-use only. It is regulated under FDA 510(k) clearance (K832766) and classified as a Class II device (product code KLT). The kit requires proper storage and handling as specified in the accompanying instructions, ensuring accuracy and reliability for clinical toxicology applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832766 | Date29 Sep 1983 | 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- Withdrawn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
- KLT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3645
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Miles Laboratories, Inc.
Questions
What is the primary purpose of the Ames TDA Disopyramide Test, and how does it work?
The Ames TDA Disopyramide Test is designed for qualitative detection of disopyramide in biological specimens, such as blood or urine. It uses an enzyme immunoassay (EIA) method to identify the presence of disopyramide, which helps clinicians monitor therapeutic levels or investigate potential poisoning cases. This test is specifically categorized under clinical toxicology assays, ensuring accurate identification for patient care.
Is this test kit meant for single-use, and if so, what does that mean for my lab’s workflow?
Yes, the kit is intended for single-use only, meaning each test strip or reagent set can only be used once. This design ensures reliability and prevents cross-contamination, which is critical for accurate toxicology testing. Your lab should plan accordingly by accounting for the number of tests needed per patient sample and avoiding reuse to maintain precision.
How should I store the Ames TDA Disopyramide Test kit to ensure its effectiveness?
Proper storage is essential for maintaining the kit’s accuracy and reliability. While the exact storage conditions aren’t detailed here, the manufacturer’s instructions (provided with the kit) will specify requirements such as temperature ranges, protection from light, and humidity control. Typically, such enzyme immunoassay kits require refrigeration or room-temperature storage depending on the formulation, so always follow the accompanying guidelines.
What regulatory pathway does this device follow, and how does that affect its use in clinical settings?
The Ames TDA Disopyramide Test was cleared through the FDA’s 510(k) process (with clearance number K832766) under the Traditional pathway, meaning it was deemed substantially equivalent to a predicate device already on the market. This classification places it as a Class II device (product code KLT), which means it undergoes additional controls to ensure safety and effectiveness. Clinically, this clearance confirms its suitability for qualitative detection in clinical toxicology, but always verify compliance with your facility’s internal protocols and local regulations.