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Emit 2000 N-Acetylprocainamide Assay and Calibrat

by Syva Co. 510(k)

Active United States

510(k) K922915

Overview

The EMIT 2000 N-Acetylprocainamide Assay and Calibrator is a homogeneous enzyme immunoassay designed for the quantitative measurement of N-acetylprocainamide in human serum or plasma. Classified as an enzyme immunoassay under product code LAN, it operates within the Clinical Toxicology specialty, enabling rapid and precise detection of the metabolite.

This assay is supplied as a reagent kit intended for use on Olympus analyzers, adhering to FDA 510(k) clearance (K922915) under Traditional review. The device is classified as Class II with Special Controls and is intended for single-use in clinical laboratory settings. No sterility or MRI safety information is specified, and regulatory authorisation is explicitly noted as FDA clearance.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922915 Date24 Aug 1992ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
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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Questions

  • What clinical specialty is this assay intended for, and how does it function within that field?

    This assay is designed for Clinical Toxicology, specifically for measuring N-acetylprocainamide—a metabolite of procainamide—in human serum or plasma. It functions as a homogeneous enzyme immunoassay, enabling rapid and precise detection of the metabolite, which is critical in assessing drug toxicity or overdose cases involving procainamide.

  • Is this device reusable, or is it meant for single-use in a lab setting?

    The EMIT 2000 N-Acetylprocainamide Assay is explicitly intended for single-use in clinical laboratory settings. It is supplied as a reagent kit, meaning each use requires a fresh application, ensuring accuracy and compliance with laboratory protocols.

  • Which analyzers are compatible with this assay, and how is it supplied?

    This assay is designed for use only on Olympus analyzers. It is supplied as a reagent kit, containing all necessary components for performing the quantitative measurement of N-acetylprocainamide in serum or plasma, as outlined in the device description.

  • What regulatory pathway was followed for FDA clearance, and what classification does this device hold?

    The EMIT 2000 N-Acetylprocainamide Assay received FDA 510(k) clearance (K922915) under the Traditional review pathway, classified as a Class II device with Special Controls. It was determined to be substantially equivalent to a predicate device, enabling its marketing under the specified regulatory framework.