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510(k) Data Aggregation
(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 < 7. | All lay users indicated that the device instructions can be easily followed. Flesch-Kincaid reading grade level < 7. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Study: For each drug (Fentanyl, Norfentanyl) and each of the 9 concentration levels, 6 tests were performed per day per device lot for 10 days, across 3 lots.
- Total Fentanyl Precision Samples: 9 concentrations * 6 tests/day * 10 days * 3 lots = 1620 tests.
- Total Norfentanyl Precision Samples: 9 concentrations * 6 tests/day * 10 days * 3 lots = 1620 tests.
- Interference Study: Not explicitly stated, but implies multiple tests for each of the many interfering substances across three batches of each device.
- Specificity Study: Not explicitly stated, but implied tests for each of the listed cross-reactants.
- Method Comparison Studies: 80 "unaltered clinical samples" (40 negative, 40 positive) were tested for each drug.
- Total Method Comparison Samples (Fentanyl): 80 samples.
- Total Method Comparison Samples (Norfentanyl): 80 samples.
- Lay-User Study: 140 lay persons participated. Urine samples were prepared at 7 different concentrations for each drug, with 20 samples per concentration.
- Total Lay-User Samples (Fentanyl): 7 concentrations * 20 samples/concentration = 140 samples.
- Total Lay-User Samples (Norfentanyl): 7 concentrations * 20 samples/concentration = 140 samples.
- Data Provenance: The text does not explicitly state the country of origin for the clinical samples. The studies are described retrospectively in the 510(k) summary, meaning data was collected prior to submission.
- For the Method Comparison Study, samples were "unaltered clinical samples," suggesting they were derived from a patient population.
- For the Precision and Lay-User studies, samples were prepared by spiking fentanyl/norfentanyl into negative urine samples/drug-free pooled urine specimens.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Precision, Interference, Specificity, Effect of Urine Specific Gravity & pH Studies:
- Ground truth for these analytical studies was established by preparing samples with known concentrations of drug, verified by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate analytical chemistry method. The experts here are implicitly the analytical chemists performing and verifying the LC/MS measurements. The number of such specialists is not specified, but LC/MS is an objective, quantitative method, rather than expert interpretation.
- Method Comparison Studies:
- The ground truth was established using LC/MS results. This is an objective analytical standard.
- The "Comparison Studies" section mentions that "three different operators" performed the comparison tests. However, these operators are performing the rapid tests and comparing them to the LC/MS ground truth, they are not establishing the ground truth themselves. The qualifications of these rapid test operators are not specified.
- Lay-User Study:
- The ground truth for the prepared samples was established by LC/MS (Liquid Chromatography-Mass Spectrometry).
- Lay users interpreted the results of the rapid test, and their interpretation was compared against the LC/MS ground truth. The "experts" here established the sample concentrations via LC/MS.
4. Adjudication Method for the Test Set
- Precision, Interference, Specificity, Effect of Urine Specific Gravity & pH, and Lay-User Studies: Ground truth was established by LC/MS. No human adjudication method (e.g., 2+1, 3+1) is described or needed for these analytical studies where the ground truth is objectively measured by a gold standard (LC/MS).
- Method Comparison Studies: The rapid test results from the three operators were directly compared to the LC/MS results. The "Discordant Results" tables list specific samples where the rapid test (by a particular operator or multiple operators) differed from the LC/MS result. There is no explicit human adjudication process described for the rapid test results against the LC/MS ground truth; it's a direct comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This device is a rapid diagnostic test (an immunoassay), not an AI-based imaging diagnostic or a device that assists human "readers" (like radiologists). Therefore, the concept of human readers improving with AI assistance does not apply here. The "operators" in the comparison study are simply performing the rapid test according to its instructions.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable in the context of this device. The ETERBIO Fentanyl/Norfentanyl Rapid Test is a physical immunoassay device where human users (either laboratory personnel or lay users for the home test) directly interpret a visible line. It is not an algorithm that produces a standalone output without human interaction.
7. The Type of Ground Truth Used
- The primary ground truth used for performance evaluation (Precision, Interference, Specificity, Method Comparison, Lay-User Studies) was LC/MS (Liquid Chromatography-Mass Spectrometry), which is an objective chemical analysis method considered the gold standard for confirming drug concentrations in urine.
- For the Lay-User Study, the ground truth of the samples was LC/MS, and the accuracy of lay user interpretation was assessed against this LC/MS truth.
8. The Sample Size for the Training Set
- This device is an immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. Therefore, this concept does not apply to the ETERBIO Fentanyl/Norfentanyl Rapid Test. Its "training" is inherent in its chemical design and manufacturing process.
9. How the Ground Truth for the Training Set Was Established
- As stated above, the device does not have a "training set" in the context of machine learning. Its analytical performance relies on validated chemical reactions and manufacturing consistency.
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