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510(k) Data Aggregation
(50 days)
Healgen**®** AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence
The Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit-Qualitative is a fluorescence immunoassay 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 with Healgen® Immunofluorescence analyzer OG-H180. This in vitro diagnostic device is for prescription use only.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to a Fentanyl test result, particularly when a preliminary positive result is obtained.
The Healgen® Immunofluorescence analyzer OG-H180 is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to detect test results from in vitro diagnostic tests on clinical specimens. This analyzer can be used in a laboratory or point-of-care setting.
The AccuFluor Fentanyl FIA Test Kit-Qualitative is a rapid fluorescence immunoassay based on the principle of competitive binding, which uses fluorescent microspheres-labeled antibody as the indicator marker to qualitatively detect fentanyl in human urine. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary action. Fentanyl, if present in the urine specimen below 1.0 ng/mL, will not saturate the binding sites of antibody-coated particles in the test device. The antibody coated fluorescence particles will then be captured by immobilized Fentanyl conjugate, and the signal will be detected in the test line (T) region to show a negative result. The signal will not be detected in the test line (T) region if the Fentanyl level exceeds 1.0 ng/mL because all the binding sites for the anti-Fentanyl antibodies will be saturated and the result will show as positive. To serve as a procedural control, a signal will be detected at the control line (C) region indicating the proper volume of specimen has been added and membrane wicking has occurred. The test is interpreted by the Healgen® Immunofluorescence analyzer OG-H180 and the result will be interpreted by the analyzer.
The provided FDA 510(k) clearance letter pertains to the Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit - Qualitative and the Healgen® Immunofluorescence Analyzer (OG-H180). This document outlines the general regulatory approval and provides some performance characteristics, but it is not a comprehensive study report detailing all aspects of the acceptance criteria and the full study that proves the device meets those criteria.
Specifically, the document does not explicitly state "acceptance criteria" as a defined set of metrics and thresholds prior to presenting performance data. Instead, it presents results from various analytical performance studies which are implicitly used to demonstrate equivalence to a predicate device. Similarly, it does not describe "human expert ground truth establishment," "adjudication methods," or "MRMC comparative effectiveness studies" because these are typically relevant for AI/ML-based diagnostic devices utilizing image interpretation or complex decision support, which is not the primary function described for this immunoassay and analyzer.
This device is an in vitro diagnostic (IVD) test for qualitative detection of fentanyl in urine, which relies on a chemical reaction read by an analyzer. Therefore, the "study" described is a series of analytical performance tests, rather than a clinical study with human readers and ground truth established by medical experts in the way that would be done for an AI radiology device, for example.
Despite these limitations in the provided text for certain categories, I will extract and infer information where possible based on the provided document and common IVD device clearance practices.
Acceptance Criteria and Device Performance for Healgen® AccuFluor Fentanyl FIA Test Kit
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document does not explicitly list pre-defined "acceptance criteria" with specific numerical thresholds for all metrics. However, based on the provided performance data, here's an interpretation of the implied criteria and the reported performance. The "acceptance criteria" inferred here are based on what constitutes successful demonstration of performance for an IVD device of this type, often aiming for high accuracy, precision, and lack of interference, especially around the cutoff concentration.
| Performance Characteristic | Implied Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Analytical Precision (Around Cutoff) | High agreement (low false negatives/positives) at concentrations near the 1.0 ng/mL cutoff. | At -25% Cutoff (0.75 ng/mL): 56-57 out of 60 negative readings across 3 lots (93.3% - 95% negative agreement). |
| At Cutoff (1.0 ng/mL): 22-24 negative and 36-38 positive readings out of 60 total across 3 lots. This demonstrates the expected transition around the cutoff. | ||
| At +25% Cutoff (1.25 ng/mL): 60 out of 60 positive readings across 3 lots (100% positive agreement). | ||
| At -100%, -75%, -50% Cutoff: 60 out of 60 negative readings. | ||
| At +50%, +75%, +100% Cutoff: 60 out of 60 positive readings. | ||
| Analytical Specificity (Cross-Reactivity) | Minimal to no cross-reactivity with common related compounds (e.g., other opioids, metabolites) or other substances found in urine, beyond expected concentrations where some cross-reactivity is acceptable and quantified. | Norfentanyl: 0.003% cross-reactivity at 30,000 ng/mL. |
| Carfentanil: 0.013% cross-reactivity at 8,000 ng/mL. | ||
| Cyclopropyl fentanyl, Para-fluoro fentanyl, Acetyl fentanyl: 100% cross-reactivity at 1 ng/mL. | ||
| Many other fentanyl analogs: various quantified cross-reactivity percentages. | ||
| Numerous unrelated compounds/metabolites: No cross-reactivity at 100 µg/mL. | ||
| Interference | No significant interference from common substances (physiological or exogenous) found in human urine at specified concentrations. | Many compounds (e.g., Acetaminophen, Ethanol, Glucose, Albumin, Hemoglobin) showed no interference at high concentrations (e.g., 100µg/mL or 1% for Ethanol) for both negative and ±50% Cut-Off fentanyl spiked samples. |
| Stability | Device maintains stated performance characteristics over its shelf life under specified storage conditions. | Stable at 2-30°C for 27 months based on real-time stability study. |
| Effect of Urine Specific Gravity & pH | Test performance (positive/negative call) should remain consistent across a physiological range of urine specific gravity and pH. | Results were consistent (all positive for samples at/above +50% Cut-Off, all negative for samples at/below -50% Cut-Off) across specific gravity 1.000-1.035 and pH 4-9. |
| Method Comparison (Clinical Samples) | High agreement (concordance) with a confirmed analytical method (LC-MS/MS) for clinical samples, especially for samples near the cutoff. | Overall Concordance: Across 3 sites, for 80 clinical samples (40 negative, 40 positive) compared to LC-MS/MS: |
| True Negative Ranges: 7 negative, 19 low negative (less than -50% cutoff) correctly identified as negative. | ||
| Near Cutoff Negative: 11-12 samples (between -50% and cutoff) correctly identified as negative, with 2-3 false positives. | ||
| Discordant Results: 6 samples near cutoff showed discordance. For example, 3 samples (0.802, 0.841, 0.916 ng/mL) were LC-MS/MS negative but device positive. 3 samples (1.013, 1.092, 1.113 ng/mL) were LC-MS/MS positive but device negative. This indicates typical variability at the qualitative cutoff. | ||
| Near Cutoff Positive: 20-21 samples (between cutoff and +50%) correctly identified as positive, with 2-3 false negatives. | ||
| High Positive: 17 samples (greater than +50%) correctly identified as positive. |
2. Sample Size Used for the Test Set and Data Provenance
- Analytical Precision: 60 replicates per concentration (6 replicates/day for 10 days) per lot, across 9 concentration levels, for 3 device lots. Total: 60 * 9 * 3 = 1620 individual tests.
- Interference: Samples with various interfering substances were tested, each at both drug-free and ±50% Cut-Off spiked fentanyl concentrations, using three batches of device. (Exact number of tests not specified, but implies a comprehensive set).
- Specificity: Various drug metabolites and other compounds tested, each using three batches of device. (Exact number of tests not specified).
- Effect of Urine Specific Gravity and pH: Samples across the specified ranges were tested at -50% and +50% Cut-Off levels by three different operators using three device lots. (Exact number of tests not specified).
- Method Comparison (Clinical Samples): 80 unaltered clinical samples (40 negative, 40 positive). These samples were run at three different testing sites.
- Data Provenance: The document does not explicitly state the country of origin for the clinical samples. It does state they were "unaltered clinical samples," implying they were retrospective real-world samples collected from patients. It does not indicate if they were prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable in the traditional sense for this device. For this IVD device, the primary ground truth for its performance studies (precision, specificity, method comparison) is established by analytical gold standards, specifically:
- LC/MS-MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) for confirming fentanyl concentrations in precision studies and as the comparator method in the method comparison study.
- This is a highly accurate and precise laboratory method for quantifying drug concentrations, and its results are considered the "ground truth" for chemical concentration data.
- There were "three different operators" for the specific gravity/pH study, but these are not "experts" in the sense of medical professionals establishing a clinical diagnosis ground truth. They are laboratory personnel performing the test.
4. Adjudication Method for the Test Set
- Not Applicable in the traditional sense. Given that the ground truth is established by LC-MS/MS, there is no human "adjudication" process like consensus reading by multiple radiologists for image interpretation. The LC-MS/MS results serve as the definitive reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance on complex interpretation tasks) is not applicable to a qualitative immunoassay and analyzer like the Healgen AccuFluor Fentanyl FIA Test Kit, which determines the presence or absence of a substance based on a fluorescent signal. The device performance is assessed on its analytical accuracy against a gold standard method.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the performance presented is primarily standalone. The Healgen® Immunofluorescence Analyzer (OG-H180) automatically interprets the fluorescent signal from the test kit. The performance data (precision, specificity, interference, method comparison) directly reflects the analytical capability of the device and test kit combination, without any human interpretation or intervention in the final "positive" or "negative" determination. A human loads the sample and the device performs the analysis and provides the result.
7. The Type of Ground Truth Used
- Analytical Gold Standard (LC-MS/MS): This is the primary method used to establish the true concentration of fentanyl in samples for precision studies and as the comparative reference for clinical samples.
- Spiked Samples: For analytical performance studies (precision, interference, specificity), known concentrations of fentanyl or interfering substances were added to negative urine samples, establishing a controlled ground truth.
8. The Sample Size for the Training Set
- Not explicitly stated in the document, and likely not applicable in the typical AI/ML sense. This device is an immunoassay, not an AI/ML diagnostic algorithm that undergoes a "training" phase with a large dataset. Immunoassays are based on biochemical principles and do not "learn" from data in the same way. Performance is optimized during development and validated analytically.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Described. As it's not an AI/ML device relying on a training set, the concept of establishing ground truth for training does not apply here. The analytical performance is characterized through rigorous testing under controlled conditions and comparison to established reference methods (like LC-MS/MS).
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