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510(k) Data Aggregation
(147 days)
The ARK Hydrocodone Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. The semi-quantitative mode is for the purpose of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method, such as Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS), or (2) permitting laboratories to establish quality control procedures.
The ARK Hydrocodone Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed positive 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 preliminary test result is positive.
The ARK Hydrocodone Assay is supplied as a liquid ready-to-use homogeneous enzyme immunoassay. The assay is based on competition between hydrocodone in the specimen and hydrocodone labeled with recombinant glucose-o-phosphate dehydrogenase (rG6PDH) for antibody binding sites. As the latter binds antibody, enzyme activity decreases. In the presence of hydrocodone from the specimen, enzyme activity increases and is directly related to the hydrocodone 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 Hydrocodone Assay consists of reagents R1 anti-hydrocodone monoclonal rabbit antibodies with substrate and R2 hydrocodone derivative labeled with bacterial recombinant G6PDH enzyme.
The provided document is a 510(k) summary for the ARK Hydrocodone Assay, an immunoassay for the qualitative detection and/or semi-quantitative estimation of hydrocodone and its metabolites in human urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly define formal "acceptance criteria" in a separate table with numerical thresholds for accuracy, precision, etc. Instead, it presents various performance characteristics that collectively demonstrate the device's suitability for its stated intended use and substantial equivalence to a predicate device. The implied acceptance criteria are that the device performs reliably and similarly to the predicate in key analytical measures.
Below is a table summarizing the reported device performance, which implicitly functions as the evidence meeting the "acceptance criteria" for analytical validation.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (Qualitative) | Consistent classification (Positive/Negative) at specified concentrations relative to the 300 ng/mL cutoff, especially near the cutoff. | 0 ng/mL: 160 Negative (N=160)75 ng/mL: 160 Negative (N=160)150 ng/mL: 160 Negative (N=160)225 ng/mL (-25% Cutoff): 160 Negative (N=160)300 ng/mL (Cutoff): 50 Negative / 110 Positive (N=160)375 ng/mL (+25% Cutoff): 160 Positive (N=160)450 ng/mL (+50% Cutoff): 160 Positive (N=160)525 ng/mL (+75% Cutoff): 160 Positive (N=160)600 ng/mL (+100% Cutoff): 160 Positive (N=160) |
| Precision (Semi-quantitative) | Consistent mean recovery and classification at specified concentrations relative to the 300 ng/mL cutoff. | 0 ng/mL: Mean 0, 160 Negative75 ng/mL: Mean 78, 160 Negative150 ng/mL: Mean 142, 160 Negative225 ng/mL: Mean 229, 160 Negative300 ng/mL (Cutoff): Mean 314, 24 Neg / 136 Pos375 ng/mL: Mean 388, 160 Positive450 ng/mL: Mean 459, 160 Positive525 ng/mL: Mean 539, 160 Positive600 ng/mL: Mean 620, 160 Positive |
| Analytical Recovery | Percent recovery close to 100% across the assay range. | Ranges from 86% to 103% (e.g., 80 ng/mL expected yielded 99% recovery, 720 ng/mL yielded 86% recovery, 800 ng/mL yielded 92% recovery). |
| Analytical Specificity (Cross-reactivity to Metabolites) | Cross-reactivity for hydrocodone should be high, while for metabolites it should be understood and ideally lower if they are not the primary target the assay is trying to quantify. | Hydrocodone: 103%Hydromorphone: 100%Hydromorphone-3β-Glucuronide: 0.7%Norhydrocodone: 13.2%Dihydrocodeine: <0.3% (at >100,000 ng/mL tested) |
| Analytical Specificity (Cross-reactivity to Structurally Related/Unrelated Compounds) | No significant cross-reactivity with other common opiate compounds or structurally unrelated substances should lead to false positives at specified concentrations. | All 30 tested structurally related or unrelated opiate compounds (e.g., Morphine, Codeine, Fentanyl, Oxycodone, Methadone, Buprenorphine, Heroin) showed NEGATIVE results at concentrations up to 100,000 ng/mL, with cross-reactivity generally <0.3% (or <0.6% for some at 50,000 ng/mL). |
| Interference (Endogenous Substances) | No interference (maintaining correct POS/NEG classification) from high concentrations of common endogenous substances. | All 17 tested endogenous substances (e.g., Acetaminophen, Creatinine, Glucose, Hemoglobin, Urea) showed no interference, maintaining NEG for 225 ng/mL hydrocodone and POS for 375 ng/mL hydrocodone. |
| Interference (Boric Acid) | No interference from boric acid. | Boric Acid (1% w/v) showed no interference, maintaining NEG for 225 ng/mL hydrocodone and NEG for 375 ng/mL hydrocodone (this second result seems like a typo in the table if it should be POS, but is recorded as NEG). Correction needed for interpretation of the Boric Acid result for 375 ng/mL hydrocodone. Given the other interference studies, it is likely it should have been POS, or implies an interfering effect with boric acid at the higher concentration. This would require clarification. |
| Specific Gravity Interference | No interference across a physiological range of urine specific gravity. | No interference observed from urine samples with specific gravity values ranging from 1.000 to 1.030, maintaining NEG for 225 ng/mL hydrocodone and POS for 375 ng/mL hydrocodone. |
| pH Interference | No interference across a physiological range of urine pH. | No interference observed from urine samples with pH values from 3.0 to 11.0, maintaining NEG for 225 ng/mL hydrocodone and POS for 375 ng/mL hydrocodone. |
| Method Comparison (Overall Concordance with LC-MS/MS) | High overall concordance with the confirmatory method (LC-MS/MS). | Overall concordance: 92.5% |
| Method Comparison (Qualitative Performance) | High sensitivity and specificity, especially around the cutoff. Discordant results should be explainable. | True Negatives: 134 samples (<150 ng/mL by LC-MS/MS) correctly identified as Negative. True Positives: 9 samples (300-450 ng/mL by LC-MS/MS) and 66 samples (>450 ng/mL by LC-MS/MS) correctly identified as Positive. Discordant Results: 8 samples (<150 ng/mL) and 8 samples (150-299 ng/mL) were assay Positive but LC-MS/MS Negative. 1 sample (300-450 ng/mL) was assay Negative but LC-MS/MS Positive. Discordances are explained as cross-reactivity with hydromorphone. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Precision Studies: N=160 for both qualitative and semi-quantitative precision (quadruplicate assays twice a day for 20 days for 8 concentration levels).
- Analytical Recovery: 5 replicates for each of the 11 concentration points across the assay range.
- Analytical Specificity (Cross-reactivity): Concentrations tested for various compounds (e.g., 100,000 ng/mL, 50,000 ng/mL). The exact number of individual tests/replicates is not specified but implied testing at least one sample per compound.
- Interference (Endogenous Substances, Boric Acid, Specific Gravity, pH): Not explicitly stated, but for Specific Gravity and pH, "N=3" is mentioned for each condition, suggesting triplicate testing.
- Method Comparison (Clinical Specimens): 226 unaltered clinical urine specimens.
- Data Provenance: The document states that the clinical urine specimens for method comparison were "unaltered clinical urine specimens that are not individually identifiable." It does not specify the country of origin or if they were retrospectively or prospectively collected. The analytical studies (precision, recovery, specificity, interference) appear to be laboratory-based studies using spiked drug-free human urine.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The ground truth for the clinical specimens in the method comparison study was established by LC-MS/MS (Liquid Chromatography/tandem Mass Spectrometry), which is stated as the "preferred confirmatory method." LC-MS/MS is an analytical chemistry technique, not a human expert interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable/provided. The ground truth was established by LC-MS/MS, an objective analytical method. Therefore, there was no need for human expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an immunoassay (a laboratory diagnostic test), not an imaging AI or a device that assists human readers in interpreting complex data. The performance study compares the device's analytical results to a gold standard analytical method (LC-MS/MS), not a human's performance.
6. If a Standalone (Algorithm Only Without Human-In-The-Loop Performance) was done:
The device itself is a "standalone" test in the sense that it provides a direct analytical result (qualitative or semi-quantitative) without human interpretation of raw data for diagnosis. The study presented (precision, analytical recovery, specificity, method comparison) evaluates the algorithm's (assay's) performance independent of direct human-in-the-loop diagnostic assistance. While a human operates the instrument and interprets the final result, the assay's core function is automated chemical analysis.
7. The Type of Ground Truth Used:
The primary ground truth used for the method comparison study was LC-MS/MS (Liquid Chromatography/tandem Mass Spectrometry) results. This is considered a highly specific and sensitive "confirmatory method" in analytical chemistry, often serving as a gold standard for drug quantification. For the other analytical studies (precision, recovery, specificity, interference), the ground truth was the known concentrations of spiked analytes into drug-free urine.
8. The Sample Size for the Training Set:
This information is not applicable/provided. This is an immunoassay, not a machine learning/AI model that requires a "training set" in the conventional sense. The "training" for such a device occurs during its development and optimization of the reagents and assay parameters by the manufacturer, rather than through a dataset in a machine learning paradigm.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, this concept doesn't directly apply here. The "ground truth" during the development and optimization of the assay would have been established through controlled laboratory experiments using known concentrations of hydrocodone and related substances, verified perhaps by independent analytical methods (e.g., HPLC, LC-MS/MS) and chemical purity assessments. The goal is to optimize the assay's sensitivity, specificity, and precision to meet performance targets.
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