(193 days)
The ARK Levetiracetam II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers. Levetiracetam concentrations can be used as an aid in management of patients treated with levetiracetam.
The ARK Levetiracetam II Assay is a homogeneous immunoassay based on competition between drug in the specimen and levetiracetam labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly related to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Levetiracetam II Assay consists of reagents R1 anti-levetiracetam monoclonal antibody with substrate and R2 levetiracetam labeled with bacterial G6PDH enzyme.
The provided text describes the performance of a diagnostic assay (ARK Levetiracetam II Assay), not an AI/ML-enabled medical device. Therefore, many of the requested criteria related to AI/ML evaluation (such as MRMC studies, training set details, expert ground truth establishment for AI) are not applicable.
However, I can extract the relevant acceptance criteria and performance data for this in-vitro diagnostic device:
Device Name: ARK Levetiracetam II Assay
Regulatory Class: Class II
Product Code: ORI
Intended Use: Quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers, as an aid in management of patients treated with levetiracetam.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from study design/CLSI guidelines) | Reported Device Performance (ARK Levetiracetam II Assay) |
|---|---|---|
| Limit of Quantitation (LoQ) | ≤20% CV precision and ±15% recovery | 2.0 µg/mL (at 2.80% CV and 95.0% recovery) |
| Measurement Range | Not explicitly stated as acceptance criterion, but established. | 2.0 - 100.0 µg/mL |
| Recovery | ±10% of the expected sample concentration | All tested concentrations (2.0-100.0 µg/mL) showed %Recovery within ±10% (e.g., 95.0% to 102.6%) |
| Linearity | Percent difference (Deviation) ±10% between predicted and observed results | All tested concentrations (2.0-100.0 µg/mL) showed %Deviation within ±10% (e.g., -6.1% to 9.5%) |
| Precision (Total CV) |
§ 862.3350 Diphenylhydantoin test system.
(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.