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Emit 2000 Digoxin Assay

by Syva Co. 510(k)

Active United States

510(k) K951755

Overview

The Emit 2000 Digoxin Assay is an enzyme immunoassay used for the quantitative measurement of digoxin in human serum or plasma. It utilizes specific reagents packaged in HDPE wedge-shaped bottles, which are compatible with various analyzers. The device is classified as an Enzyme Immunoassay, Digoxin, with a product code of KXT. It is a Class II device with special controls. The assay is homogeneous, meaning it does not require separation of the reaction mixture.

The Emit 2000 Digoxin Assay is supplied with specific reagents and is compatible with certain analyzers, including the OLYMPUS AU400/600, AU800/1000, and AU2700 series. The device has been cleared by the FDA with a 510(k) clearance, specifically K951755. The clearance was issued after a review of the device's substantial equivalence to a predicate device. The device is used in clinical toxicology settings and has a registration number associated with it.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK951755 Date1 Jun 1995ClearedStatusActive

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
KXT
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 is the Emit 2000 Digoxin Assay used for?

    The Emit 2000 Digoxin Assay is used for the quantitative measurement of digoxin in human serum or plasma, typically in clinical toxicology settings.

  • Is the Emit 2000 Digoxin Assay compatible with multiple analyzers?

    Yes, the Emit 2000 Digoxin Assay is compatible with certain analyzers, including the OLYMPUS AU400/600, AU800/1000, and AU2700 series.

  • What type of clearance does the Emit 2000 Digoxin Assay have?

    The Emit 2000 Digoxin Assay has been cleared by the FDA with a 510(k) clearance, specifically K951755, indicating substantial equivalence to a predicate device.

  • What is the product code for the Emit 2000 Digoxin Assay?

    The product code for the Emit 2000 Digoxin Assay is KXT, classified as an Enzyme Immunoassay, Digoxin.