Stratus N-Acetylprocainamide Fluorometric Enzyme I

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K853547 ↗

FDA Product Code

LAN

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What is the Stratus N-Acetylprocainamide Fluorometric Enzyme I used for?

  This device measures N-acetylprocainamide (NAPA) levels in biological samples. NAPA is a metabolite of procainamide, a medication used to treat heart rhythm disorders. Monitoring NAPA helps clinicians assess how the body metabolizes procainamide and detect potential toxicity, ensuring safer drug therapy in toxicology settings.

• How is the Stratus N-Acetylprocainamide Fluorometric Enzyme I supplied and used?

  The device is supplied as a single-use, reagent-based immunoassay designed for use with the Stratus system. Each assay requires proper handling and storage as outlined in the accompanying documentation. It employs fluorometric technology to detect and quantify NAPA concentrations in clinical laboratory settings.

• Is the Stratus N-Acetylprocainamide Fluorometric Enzyme I sterile?

  The device is intended for single-use in clinical toxicology laboratories. Sterility is maintained through proper packaging and handling procedures specified in the manufacturer’s instructions to ensure reliable results.

• What regulatory approval does the Stratus N-Acetylprocainamide Fluorometric Enzyme I hold?

  The device has been cleared by the FDA under 510(k) authorization (K853547) and is classified as a Class II medical device under product code LAN. This clearance confirms its substantial equivalence to a predicate device and compliance with applicable regulatory requirements.

• Can this device be reused, or is it designed for single-use only?

  The Stratus N-Acetylprocainamide Fluorometric Enzyme I is explicitly designed for single-use. Reuse is not recommended or supported, as it could compromise accuracy, sterility, and regulatory compliance. Each assay must be used once and discarded.