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K Number
K011920
Device Name
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
Manufacturer
SYVA CO., DADE BEHRING, INC.
Date Cleared
2001-07-02

(12 days)

Product Code
KXT
Regulation Number
862.3320
Type
Special
Panel
TX
Reference & Predicate Devices
K003463
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of digoxin in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

Device Description

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the Emit® 2000 Digoxin Assay, and it primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table and study details. The only relevant information gathered from the text is:

  • Device Name: Emit® 2000 Digoxin Assay
  • Intended Use: Quantitative analysis of digoxin in human serum or plasma. Used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy.
  • Nature of comparison: The modified assay is similar to the predicate device with minor differences in the packaging (smaller fill volume, different shaped reagent bottles, barcode label compatible with OLYMPUS® AU analyzers). The manufacturer states, "The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." This suggests performance characteristics are assumed to be a match to the predicate, rather than independently proven, for the purpose of this 510(k).

§ 862.3320 Digoxin test system.

(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.