Procainamide Assay for the Bayer Immuno 1 System

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K971716 ↗

FDA Product Code

LAR

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 Procainamide Assay for the Bayer Immuno 1 System used for?

  This assay measures procainamide concentrations in human serum or plasma to monitor therapeutic levels and prevent toxicity. Procainamide is an antiarrhythmic drug used to treat cardiac arrhythmias, and its precise quantification aids clinicians in adjusting dosages for optimal efficacy while avoiding adverse effects like overdose.

• How is the Procainamide Assay supplied, and is it single-use?

  The assay is supplied as a reagent kit designed exclusively for the Bayer Immuno 1 System. It is intended for single-use only, adhering to standard in vitro diagnostic practices. Each kit is packaged for one-time use to ensure accuracy and reliability in clinical toxicology testing.

• Does the Procainamide Assay require sterility beyond standard laboratory practices?

  No specific sterility requirements beyond routine laboratory hygiene are stated for this assay. Since it is an in vitro diagnostic device used in controlled clinical laboratory settings, adherence to general aseptic techniques during handling and testing is expected to maintain integrity and prevent contamination.

• What type of immunoassay technique does the Procainamide Assay use?

  The assay employs the Enzyme Multiplied Immunoassay Technique (EMIT), a widely recognized method for enzyme immunoassays. EMIT enhances sensitivity and specificity by amplifying the enzymatic reaction, providing accurate and reproducible procainamide concentration measurements for clinical decision-making.

• How should the Procainamide Assay be stored, and what documentation covers storage guidelines?

  Storage conditions are detailed in the accompanying manufacturer documentation, which outlines specific requirements such as temperature and expiration dates. Proper storage is critical to preserve assay integrity and performance, ensuring reliable results when monitoring procainamide levels in patient samples.