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510(k) Data Aggregation
(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 (<0.5 ng/mL LC-MS/MS): 50/51 (98%) Negative by ARK (1 discordant positive). Near Cutoff Negative (0.5-0.9 ng/mL LC-MS/MS): 20 positive, 3 negative by ARK (23 total). Near Cutoff Positive (1.0-1.5 ng/mL LC-MS/MS): 12 positive, 0 negative by ARK (12 total). |
| Calibration Curve Stability | Maintain effectiveness for a specified period. | Effective up to at least 15 days. |
2. Sample size used for the test set and the data provenance
- Precision Test Set: Not explicitly stated as a separate "test set" but 160 analyses were performed for each of 9 fentanyl concentration levels, totaling 1440 analyses.
- Analytical Specificity / Interference Test Set: Concentrations of various compounds were spiked into drug-free, negative human urine. The number of individual urine samples used is not specified, but the testing was performed on Beckman Coulter AU680.
- Method Comparison Test Set: A total of 150 unaltered clinical urine specimens.
- Data Provenance: The document states "human urine" was used for testing, and for the method comparison, it specifies "unaltered clinical urine specimens that are not individually identifiable." No specific country of origin is mentioned, but the context implies it was likely conducted in the US, given the FDA submission. The studies appear to be prospective as they were specifically designed and conducted to evaluate the device's performance for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is an in-vitro diagnostic (IVD) immunoassay for detecting a chemical (fentanyl) in urine, not an image-based AI device requiring expert interpretation of medical images. The "ground truth" for the method comparison was established by a laboratory-based confirmatory method, LC-MS/MS (Liquid Chromatography/tandem Mass Spectrometry).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for this type of IVD device. Adjudication methods like "2+1" or "3+1" are typically used in medical imaging studies where human readers provide interpretations that need to be reconciled to establish a consensus ground truth. Here, the ground truth is an analytical measurement (LC-MS/MS).
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
This is not applicable. The device is an automated immunoassay, which does not involve human readers for interpretation, nor is it an AI-assisted diagnostic tool. Its performance is compared against a gold-standard laboratory method (LC-MS/MS).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented (Precision, Analytical Specificity, Interference, and Method Comparison) represent the standalone performance of the ARK Fentanyl Assay, as it is an automated immunoassay performed on clinical chemistry analyzers, without human intervention for result interpretation beyond the machine's output. The device itself is the "algorithm only" in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the method comparison study was established by LC-MS/MS (Liquid Chromatography/tandem Mass Spectrometry), which is considered a definitive confirmatory chemical method for fentanyl detection.
8. The sample size for the training set
This information is not provided in the document. The document describes performance validation studies for the device, but it does not detail the internal development or "training" process (if any, in the context of an immunoassay optimization rather than machine learning). Immunoassays are biochemically developed systems, not typically "trained" on data sets in the same way an AI algorithm is.
9. How the ground truth for the training set was established
As the document does not describe a "training set" in the context of machine learning, this information is not applicable. The development of an immunoassay involves extensive biochemical research, optimization, and validation using well-characterized samples, rather than a data-driven "training" process with a ground truth dataset in the AI sense. The calibrators and controls used are prepared by volumetric dilution of high purity fentanyl traceable to HPLC into drug-free human urine.
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