(110 days)
The ARK Fentanyl Assay is an immunoasay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.
The ARK Fentanyl Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the prelininary test result is positive.
The ARK Fentanyl Assay is a homogeneous enzyme immunoassay technique used for the analysis of a specific compound in human urine. The assay is based on competition between drug in the specimen and drug labeled with recombinant glucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly proportional to the drug concentration. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous G6PDH does not interfere because the coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Fentanyl Assay consists of reagents R1 anti-fentanyl polyclonal antibody with substrate and R2 fentanyl derivative labeled with bacterial recombinant G6PDH enzyme.
The provided text describes the performance characteristics of the ARK Fentanyl Assay, an immunoassay for the qualitative detection of fentanyl in human urine. Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a typical quantitative pass/fail table format for all parameters. Instead, it presents various performance studies with their results, implying that these results met the internal criteria for the manufacturer to claim substantial equivalence. The precision table comes closest to showing performance relative to a cutoff.
| Performance Characteristic | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Precision | Clarity on positive/negative results around cutoff (1.0 ng/mL) | At Cutoff (1.0 ng/mL): 97 Negative, 63 Positive results out of 160. |
| At +25% Cutoff (1.25 ng/mL) and above: 160/160 (100%) Positive. | ||
| At -25% Cutoff (0.75 ng/mL) and below: 160/160 (100%) Negative. | ||
| Analytical Specificity (Cross-reactivity) | Detection of fentanyl and its major metabolite (Norfentanyl); minimal cross-reactivity with other substances. | Norfentanyl: 10% cross-reactivity (at 2.5 ng/mL). Other fentanyl analogs showed varying cross-reactivity (e.g., Acetyl fentanyl: 83.33% at 1.2 ng/mL). |
| Other opioids, structurally similar, and functional analogs tested negative at high concentrations (e.g., Morphine: 100 µg/mL). | ||
| Interference (Structurally Unrelated Compounds) | No false results in presence of common drugs/substances. | No false negative or false positive results observed for 36 tested compounds at high concentrations (e.g., Acetaminophen 500 µg/mL, Ibuprofen 500 µg/mL) when spiked into urine at ±50% of the cutoff concentration. |
| Interference (Endogenous Substances) | No interference from common endogenous substances in urine. | No interference observed for 14 tested endogenous substances (e.g., Acetone 1000 mg/dL, Glucose 3000 mg/dL) at high concentrations when spiked into urine at ±50% of the cutoff concentration. |
| Interference (Specific Gravity & pH) | No interference across physiological range. | No interference observed for specific gravity (1.001 to 1.030) and pH (3.0 to 11.0) when tested at ±50% of the cutoff concentration. |
| Interference (Boric Acid) | No interference. | No interference observed with 1% w/v boric acid when tested at ±50% of the cutoff concentration. |
| Method Comparison (Concordance with LC-MS/MS) | High agreement with confirmatory method, especially at and away from cutoff. | Total samples: 150. |
| High Positive (>1.5 ng/mL LC-MS/MS): 64/64 (100%) Positive by ARK. | ||
| **Low Negative ( |
§ 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).