(25 days)
The LZI Fentanyl II Enzyme Immunoassay is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
The LZI Fentanyl II Enzyme Immunoassay is a homogeneous enzyme immunoassay with readyto-use liguid reagents. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. The drug-labeled G6PDH conjugate is traceable to a commercially available fentanyl standard and referred to as fentanyl-labeled G6PDH conjugate. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, fentanyl-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug; the unbound fentanyllabeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The LZI Fentanyl II Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit. The LZI Fentanyl II Enzyme Immunoassay is traceable to a commercially available fentanyl standard.
The R1 solution contains mouse monoclonal anti-fentanyl antibody, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with fentanyl in buffer with sodium azide (0.09 %) as a preservative.
The LZI Fentanyl II Enzyme Immunoassay is intended for the qualitative determination of norfentanyl in human urine at a cutoff value of 5 ng/mL. The device provides a preliminary analytical result, and a more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used for a confirmed analytical result.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Precision | Ability to consistently produce correct qualitative results (Negative/Positive) for samples with concentrations at various percentages around the 5 ng/mL cutoff (0%, 25%, 50%, 75%, 100%, 125%, 150%, 175%, 200%). | Within Run (N=22): All 0%, 25%, 50%, 75% negative samples were Negative. All 125%, 150%, 175%, 200% positive samples were Positive. 100% cutoff samples were 13 Neg/9 Pos (indicating some variability around the cutoff, which is expected for qualitative assays at the cutoff). |
| Total Precision (N=88): All 0%, 25%, 50%, 75% negative samples were Negative. All 125%, 150%, 175%, 200% positive samples were Positive. 100% cutoff samples were 59 Neg/29 Pos. | ||
| Method Comparison (Qualitative Accuracy) | Comparison of EIA results with LC/MS confirmation for clinical samples, especially focusing on false positives and false negatives within different concentration ranges relative to the cutoff. Acceptable levels of agreement and defined explanations for discrepancies. | Overall Accuracy: 20/20 negative samples (by LC/MS) were EIA Negative. 19/19 samples |
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).