(147 days)
Immunoassay for the in vitro quantitative determination of digoxin in human serum and plasma. Measurements are used in the diagnosis and treatment of digoxin overlose and in monitoring levels of digoxin to ensure proper therapy. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
The Elecsys Digoxin assay employs a competitive test principle using a monoclonal antibody specifically directed against digoxin. Digoxin in the sample competes with the added digoxin derivative labeled with biotin for the binding sites on the ruthenylated antibody-complex. Results are determined via a calibration curve which is instrument- specifically generated by 2point calibration and a master curve provided via the reagent barcode. The reagent working solutions include: RackPack (kit placed on instrument) M: Streptavidin-coated microparticles, R1: Anti digoxin AbRu(bpy) 3+ and R2: Digoxin-derivativebiotin. PreciControl Cardiac II is a lyophilized control serum based on human serum in two concentration ranges. The controls are used for monitoring the accuracy and precision of the Elecsys CK MB, CK MB STAT, Myoglobin, Myoglobin STAT, proBNP II, proBNP II STAT, and Digoxin immunoassays.
The provided document is a 510(k) summary for the Elecsys Digoxin Immunoassay and Elecsys PreciControl Cardiac II. It describes the device, its intended use, and various performance evaluations conducted.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document lists performance characteristics in a comparative table (Table 1 and Table 2) between the "Predicate Device Elecsys Digoxin Immunoassay (K973112)" and the "Candidate Device Elecsys Digoxin Immunoassay." While specific acceptance criteria are not explicitly stated for each test, the reported performance data for the candidate device can be listed. The comparison to the predicate device implies that the candidate device's performance should be equivalent or better.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Comparison/General IVD Standards) | Reported Device Performance (Candidate Device) |
|---|---|---|
| Measuring Range | At least 0.150 (LDL)-5.00 ng/mL | 0.4 ng/mL (LoQ) – 5.00 ng/mL |
| Precision (Repeatability-cobas e 411) | Generally, low CV ( |
§ 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.