EMIT-CAD Procainamide Assay
by Syva Co. 510(k)
Active
510(k) K811770
Overview
The EMIT-CAD Procainamide Assay is an enzyme immunoassay designed for the quantitative measurement of procainamide concentrations in biological samples. It falls under the category of clinical toxicology assays, enabling rapid and accurate detection of procainamide levels, a medication used to treat certain heart rhythm disorders. This assay leverages enzyme-multiplied immunoassay technique (EMIT) for high sensitivity and specificity in detecting procainamide and its metabolites.
This assay is supplied as a reagent kit for in vitro diagnostic use in clinical laboratories. It is intended for single-use applications and requires no special storage conditions beyond refrigeration. The device is classified under product code LAR and is regulated under FDA 510(k) clearance (K811770), adhering to Class II special controls for enzyme immunoassays. No MRI safety or reusable components are indicated in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811770 | Date10 Jul 1981 | 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- Withdrawn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
- LAR
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3320
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the EMIT-CAD Procainamide Assay used for?
The EMIT-CAD Procainamide Assay is designed for the quantitative measurement of procainamide concentrations in biological samples. It is specifically used in clinical toxicology to detect and monitor procainamide levels, a medication prescribed for treating certain heart rhythm disorders. The assay provides rapid and accurate results, helping clinicians assess patient compliance, toxicity, or therapeutic effectiveness.
How is the EMIT-CAD Procainamide Assay supplied, and what are its storage requirements?
The EMIT-CAD Procainamide Assay is supplied as a reagent kit intended for in vitro diagnostic use in clinical laboratories. It is a single-use product, meaning each kit is meant for one testing procedure. Storage is simple: the kit requires no special conditions beyond standard refrigeration, ensuring stability and reliability for its intended use.
Is the EMIT-CAD Procainamide Assay reusable, or is it intended for single-use only?
The EMIT-CAD Procainamide Assay is explicitly designed for single-use applications. This means each kit is intended to be used once for testing procainamide levels in biological samples. The manufacturer does not recommend or support reuse, as this could compromise accuracy, sterility, or performance.
What regulatory pathway does the EMIT-CAD Procainamide Assay follow?
The EMIT-CAD Procainamide Assay follows the FDA 510(k) clearance pathway, classified under product code LAR (Laboratory Reagents). It was granted clearance under the traditional 510(k) process with the decision code SESE (Substantially Equivalent) by the FDA’s Texas Advisory Committee in 1981. This classification ensures it meets Class II special controls for enzyme immunoassays.
Does the EMIT-CAD Procainamide Assay require any special handling or preparation before use?
The EMIT-CAD Procainamide Assay is a reagent kit designed for use in clinical laboratories with standard laboratory practices. While no special handling is explicitly mentioned beyond refrigeration, it is assumed that users should follow the manufacturer’s included instructions for proper sample preparation, calibration, and assay procedure. This ensures accurate and reliable results for procainamide quantification.