(54 days)
The ETERBIO Fentany]Norfentary] Rapid Test (Colloidal Gold) is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine:
| Drug (Identifier) | Calibrator | Cut-off Level |
|---|---|---|
| Fentanyl (FYL) | Fentanyl | 1ng/mL |
| Norfentanyl (NFYL) | Norfentanyl | 5ng/mL |
The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. It provides a preliminary screening result only. For a confirmed analytical outcome, a more specific chemical is required. GC/MS or LC/MS is the preferred confirmatory method.
The ETERBIO Fentanyl Norfentanyl Home Test is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine:
| Drug (Identifier) | Calibrator | Cut-off Level |
|---|---|---|
| Fentanyl (FYL) | Fentanyl | 1ng/mL |
| Norfentanyl (NFYL) | Norfentanyl | 5ng/mL |
The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. This test provides only preliminary results. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.
Rapid Test ETERBIO Fentanyl/Norfentanyl Gold) and ETERBIO The Fentanyl/Norfentanyl Home Test are immunoassays intended for the qualitative detection of fentanyl and norfentanyl in human urine. Each ETERBIO fentanyl/norfentanyl urine test device consists of a Test Panel and a package insert. Each Test Panel is sealed with sachets of desiccant in an aluminum pouch.
The provided text describes the performance characteristics of the ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) and ETERBIO Fentanyl/Norfentanyl Home Test, which are immunoassay devices for qualitative detection of Fentanyl and Norfentanyl in human urine.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria for Performance (Implicit)
The document primarily details the analytical performance and comparison studies without explicitly stating numeric "acceptance criteria" for precision, specificity, or comparison study concordance rates. However, the reported results demonstrate that the device performs as expected for a qualitative drug test around the specified cutoff levels. For the Lay-User Study, the implicit acceptance criterion is a high percentage of correct results and ease of understanding for lay users.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from context) | Reported Device Performance (Fentanyl) | Reported Device Performance (Norfentanyl) |
|---|---|---|---|
| Precision | Consistent results across multiple runs and lots, especially near the cutoff concentration. Optimal: 0% false positives/negatives at concentrations far from cutoff, and a mix of positive/negative results near cutoff as expected for qualitative tests. | * -100% to -50% cut off: 60-/0+ (100% negative) across 3 lots. |
- -25% cut off: Lot 1: 60-/0+, Lot 2: 59-/1+, Lot 3: 60-/0+.
- Custom Cutoff Concentration (not explicitly stated): Lot 1: 27+/33-, Lot 2: 26+/34-, Lot 3: 26+/34-.
- +25% to +100% cut off: 60+/0- (100% positive) across 3 lots. | * -100% to -50% cut off: 60-/0+ (100% negative) across 3 lots.
- -25% cut off: Lot 1: 58-/2+, Lot 2: 58-/2+, Lot 3: 59-/1+.
- Custom Cutoff Concentration (not explicitly stated): Lot 1: 27+/33-, Lot 2: 26+/34-, Lot 3: 26+/34-.
- +25% to +100% cut off: 60+/0- (100% positive) across 3 lots. |
| Stability | Device remains stable and functional for a specified shelf life. | 24 months at 36-86°F based on real stability study. | 24 months at 36-86°F based on real stability study. |
| Interference | No interference from common physiological/pathological substances or specified concentrations of other compounds. | No interference observed from a comprehensive list of 60+ compounds at specified concentrations (e.g., Acetaminophen, Ethanol, Albumin, Glucose, etc.) | No interference observed from a comprehensive list of 60+ compounds at specified concentrations (e.g., Acetaminophen, Ethanol, Albumin, Glucose, etc.) |
| Specificity (Cross-Reactivity) | Minimal to no cross-reactivity with structurally similar but non-target compounds, and non-opioid compounds. Appropriate cross-reactivity with relevant metabolites. | Fentanyl: 100% cross-reactivity with Fentanyl at 1 ng/mL. Cross-reactivity observed with several fentanyl analogues (e.g., Acetyl fentanyl (83.3%), Acrylfentanyl (83.3%), Butyryl fentanyl (62.5%), Furanyl fentanyl (57.1%), Isobutyryl fentanyl (66.7%), Ocfentanil (66.7%), Para-fluoro fentanyl (33.3%), Para-fluorobutyryl fentanyl (33.3%), Valeryl fentanyl (40%)). Low/no cross-reactivity with others. | Norfentanyl: 100% cross-reactivity with Norfentanyl at 5 ng/mL. Cross-reactivity observed with several fentanyl analogues (e.g., (+)-3-cis-methyl fentanyl (50%), Acetyl fentanyl (50%), Acrylfentanyl (50%), Butyryl fentanyl (50%), Furanyl fentanyl (55.6%), Isobutyryl fentanyl (62.5%), Para-fluoro fentanyl (100%)). Low/no cross-reactivity with others. |
| Effect of Urine Specific Gravity & pH | Consistent results across a range of urine specific gravity and pH levels. | All samples at and above +50% Cut-Offs were positive; all samples at and below -50% Cut-Offs were negative, for specific gravity 1.000-1.035 and pH 4-9. | All samples at and above +50% Cut-Offs were positive; all samples at and below -50% Cut-Offs were negative, for specific gravity 1.000-1.035 and pH 4-9. |
| Method Comparison (Concordance with LC/MS) | High concordance with results from LC/MS (Liquid Chromatography-Mass Spectrometry), especially for samples far from the cutoff. Some discordance expected near cutoff. | Fentanyl:
- High agreement for Low Negative and High Positive samples (100% for most operators).
- Discordant results mainly near cutoff (e.g., some LC/MS negatives read as positive, some LC/MS positives read as negative). For example, Operator 1 had 1 negative result with LC/MS result (1.01 ng/mL) and 2 positive results with LC/MS results (0.986 ng/mL, 0.937 ng/mL). | Norfentanyl:
- High agreement for Low Negative and High Positive samples (100% for most operators).
- Discordant results mainly near cutoff. For example, Operator 1 had 1 negative result with LC/MS result (5.2 ng/mL) and 1 positive result (4.85 ng/mL). |
| Lay-User Study (Accuracy) | High percentage of correct results by lay users, demonstrating ease of use and interpretability. | Fentanyl: 100% correct for samples at -100%, -75%, -50% cutoff, and +25%, +50%, +75% cutoff. 95% correct at -25% cutoff.
Norfentanyl: 100% correct for samples at -100%, -75%, -50%, -25% cutoff, and +25%, +50%, +75% cutoff. | Fentanyl: 100% correct for samples at -100%, -75%, -50% cutoff, and +25%, +50%, +75% cutoff. 95% correct at -25% cutoff.
Norfentanyl: 100% correct for samples at -100%, -75%, -50%, -25% cutoff, and +25%, +50%, +75% cutoff. |
| Lay-User Study (Usability) | Instructions are easily understood and followed by lay users. | All lay users indicated that the device instructions can be easily followed. Flesch-Kincaid reading grade level
§ 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).