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510(k) Data Aggregation
(193 days)
ARK Diagnostics, Inc.
The ARK Levetiracetam II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers. Levetiracetam concentrations can be used as an aid in management of patients treated with levetiracetam.
The ARK Levetiracetam II Assay is a homogeneous immunoassay based on competition between drug in the specimen and levetiracetam labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly related to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Levetiracetam II Assay consists of reagents R1 anti-levetiracetam monoclonal antibody with substrate and R2 levetiracetam labeled with bacterial G6PDH enzyme.
The provided text describes the performance of a diagnostic assay (ARK Levetiracetam II Assay), not an AI/ML-enabled medical device. Therefore, many of the requested criteria related to AI/ML evaluation (such as MRMC studies, training set details, expert ground truth establishment for AI) are not applicable.
However, I can extract the relevant acceptance criteria and performance data for this in-vitro diagnostic device:
Device Name: ARK Levetiracetam II Assay
Regulatory Class: Class II
Product Code: ORI
Intended Use: Quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers, as an aid in management of patients treated with levetiracetam.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from study design/CLSI guidelines) | Reported Device Performance (ARK Levetiracetam II Assay) |
|---|---|---|
| Limit of Quantitation (LoQ) | ≤20% CV precision and ±15% recovery | 2.0 µg/mL (at 2.80% CV and 95.0% recovery) |
| Measurement Range | Not explicitly stated as acceptance criterion, but established. | 2.0 - 100.0 µg/mL |
| Recovery | ±10% of the expected sample concentration | All tested concentrations (2.0-100.0 µg/mL) showed %Recovery within ±10% (e.g., 95.0% to 102.6%) |
| Linearity | Percent difference (Deviation) ±10% between predicted and observed results | All tested concentrations (2.0-100.0 µg/mL) showed %Deviation within ±10% (e.g., -6.1% to 9.5%) |
| Precision (Total CV) |
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(166 days)
ARK Diagnostics, Inc.
The ARK Methotrexate II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of methotrexate to help ensure appropriate therapy. Specimens from patients who have received glucarpidase (carboxypeptidase G2) as a high dose methotrexate rescue therapy should not be tested with the ARK Methotrexate II Assay.
The ARK Methotrexate II Assay is a homogeneous immunoassay based on competition between drug in the specimen and methotrexate labeled with the recombinant enzyme glucose-6phosphate dehydrogenase (rG6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly related to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenyzme NAD functions only with the bacterial enzyme (rG6PDH) used in the assay. The ARK Methotrexate II Assay consists of reagents R1 anti-methotrexate monoclonal antibody with substrate and R2 methotrexate labeled with recombinant G6PDH enzyme. The test system includes the ARK Methotrexate II Calibrator, ARK Methotrexate II Control, and ARK Methotrexate II Dilution Buffer.
The ARK Methotrexate II Assay is a homogeneous enzyme immunoassay for the quantitative determination of methotrexate in human serum or plasma.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Device Performance (Reported) |
|---|---|
| Limit of Quantitation (LoQ) | Established as 0.030 umol/L. Acceptable inter-assay precision ( |
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(147 days)
ARK Diagnostics, Inc.
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 Negative |
| 75 ng/mL: Mean 78, 160 Negative | ||
| 150 ng/mL: Mean 142, 160 Negative | ||
| 225 ng/mL: Mean 229, 160 Negative | ||
| 300 ng/mL (Cutoff): Mean 314, 24 Neg / 136 Pos | ||
| 375 ng/mL: Mean 388, 160 Positive | ||
| 450 ng/mL: Mean 459, 160 Positive | ||
| 525 ng/mL: Mean 539, 160 Positive | ||
| 600 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: 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 450 ng/mL by LC-MS/MS) correctly identified as Positive. |
| Discordant Results: 8 samples ( |
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(469 days)
ARK Diagnostics, Inc.
The ARK Lacosamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lacosamide in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of lacosamide to help ensure appropriate therapy.
The ARK Lacosamide Assay is a homogeneous enzyme immunoassay based on competition between drug in the specimen and lacosamide labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly related to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Lacosamide Assay consists of reagents R1 anti-lacosamide polyclonal antibody with substrate and R2 lacosamide labeled with bacterial G6PDH enzyme.
The provided text describes the ARK Lacosamide Assay, a homogeneous enzyme immunoassay for quantitative determination of lacosamide in human serum. This device is intended for monitoring lacosamide levels to ensure appropriate therapy. The substantial equivalence is demonstrated through comparative testing against a predicate device (ARKTM Topiramate Assay, K083799) and various performance characteristic studies.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LoQ) | Acceptable inter-assay precision (1.00 µg/mL) or ≤0.20 µg/mL (for ≤1.00 µg/mL) between 1st and 2nd order regressed values. | Linear relationship demonstrated between 0.40 and 25.00 µg/mL (y = 0.9998x - 0.0170). Differences within acceptable limits. |
| Precision (Total CV) | ≤10% total CV | For controls and human serum samples, total CVs ranged from 3.9% to 4.5%. |
| Interfering Substances | Measurement of lacosamide resulted in ≤10% error | All tested interfering substances resulted in ≤10% error (recoveries ranging from 95.8% to 103.5%). |
| Specificity (O-Desmethyl Metabolite) | Not clinically significant ( |
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(30 days)
ARK Diagnostics, Inc.
The ARK Fentanyl II Assay is an 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 in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.
The ARK Fentanyl II Assay provides only a preliminary analytical 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 Fentanyl II 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 related 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 serum G6PDH does not interfere because the coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Fentanyl II Assay consists of reagents R1 anti-fentanyl monoclonal antibodies with substrate and R2 fentanyl derivative labeled with bacterial recombinant G6PDH enzyme.
1. Acceptance Criteria and Reported Device Performance for ARKTM Fentanyl II Assay
The provided text details the performance characteristics of the ARKTM Fentanyl II Assay, which is an immunoassay for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The study evaluates precision, analytical specificity (cross-reactivity with structurally similar compounds and lack of interference from structurally unrelated compounds and endogenous substances), and method comparison with LC-MS/MS.
Here's a table summarizing the acceptance criteria (implied by the data presentation for each test) and the reported device performance:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (Qualitative) | Samples below the cutoff (e.g., -100%, -75%, -50%, -25% of cutoff) should consistently test Negative. | - 0.00 ng/mL (-100%): 160 Negative (out of 160) |
- 0.25 ng/mL (-75%): 160 Negative (out of 160)
- 0.50 ng/mL (-50%): 160 Negative (out of 160)
- 0.75 ng/mL (-25%): 160 Negative (out of 160)
- 1.00 ng/mL (Cutoff): 84 Negative; 76 Positive (out of 160)
- 1.25 ng/mL (+25%): 160 Positive (out of 160)
- 1.50 ng/mL (+50%): 160 Positive (out of 160)
- 1.75 ng/mL (+75%): 160 Positive (out of 160)
- 2.00 ng/mL (+100%): 160 Positive (out of 160) |
| | Samples above the cutoff (e.g., +25%, +50%, +75%, +100% of cutoff) should consistently test Positive. | |
| | Samples at the cutoff should show a mix of Negative and Positive results, indicating proper cutoff discrimination. | |
| Analytical Specificity | Norfentanyl (major metabolite) should show some cross-reactivity. Other fentanyl structural analogs/metabolites may show varying degrees of cross-reactivity. Structurally similar opioids and functional analogs should be negative at high concentrations. | - Norfentanyl: 7% cross-reactivity at 15 ng/mL. - Acetyl fentanyl, Isobutyryl fentanyl: 90.91% cross-reactivity at 1.1 ng/mL.
- Furanyl fentanyl, Para-fluoro fentanyl: 66.67% cross-reactivity at 1.5 ng/mL.
- Other similar compounds (e.g., Carfentanil, Sufentanil, Alfentanil): show very low to 1.5 ng/mL`: 0 Negative, 62 Positive (62 concordant positives)
- Discordant Results Explanation: The 1 discordant positive at
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(110 days)
ARK Diagnostics, Inc.
The ARK Tramadol Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of tramadol in human urine at a cutoff concentration of 100 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 semiquantitative 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 Tramadol 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 Tramadol Assay is a homogeneous enzyme immunoassay technique used for the analysis of tramadol 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 related 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 Tramadol Assay consists of reagents R1 anti-tramadol rabbit polyclonal antibody with substrate and R2 tramadol derivative labeled with bacterial recombinant G6PDH enzyme.
The provided text describes the performance characteristics of the ARK Tramadol Assay, an immunoassay for detecting tramadol in human urine. Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a bulleted or numbered list with corresponding "reported performance." However, the performance parameters evaluated and the results presented implicitly define the acceptance criteria for the device to be considered substantially equivalent to the predicate. Based on the provided data, the implicit acceptance criteria and the device's performance are:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Precision (Qualitative): Reliable classification of samples as negative below -25% cutoff, positive above +25% cutoff, and expected indeterminate results around the cutoff. | At 0.0, 25.0, 50.0, and 75.0 ng/mL (below -25% cutoff), all 160 determinations were Negative. |
| At 125.0, 150.0, 175.0, and 200.0 ng/mL (above +25% cutoff), all 160 determinations were Positive. | |
| At the 100 ng/mL Cutoff, results were 83 Negative/77 Positive (demonstrating expected variability around the cutoff). | |
| Precision (Semiquantitative): Accurate mean concentration values for different spiked levels and reliable classification (negative below -25% cutoff, positive above +25% cutoff). | Mean concentrations closely matched nominal values (e.g., 29.2 ng/mL for 25.0 ng/mL samples, 189.0 ng/mL for 200.0 ng/mL samples). |
| At 0.0, 25.0, 50.0, and 75.0 ng/mL, all 160 determinations were Negative. | |
| At 125.0, 150.0, 175.0, and 200.0 ng/mL, all 160 determinations were Positive. | |
| At the 100 ng/mL Cutoff, results were 97 Negative/63 Positive (demonstrating expected variability around the cutoff). | |
| Analytical Recovery: Percentage recovery for various tramadol concentrations should be within an acceptable range (e.g., likely 80-120% or 90-110%, though not explicitly stated). | Recovery percentages ranged from 90.4% to 109.1% across concentrations from 50.0 to 1000.0 ng/mL, indicating good analytical recovery. |
| Analytical Specificity (Tramadol Metabolites): Known metabolites should exhibit a specific level of cross-reactivity, allowing detection without excessive interference from non-target compounds at the cutoff. | O-Desmethyltramadol: 16.67% cross-reactivity (positive at 600 ng/mL for 100 ng/mL cutoff). |
| N-Desmethyltramadol: 66.67% cross-reactivity (positive at 150 ng/mL for 100 ng/mL cutoff). This demonstrates the assay's ability to react with key metabolites. | |
| Analytical Specificity (Structurally-Related Compounds): Structurally related compounds (not metabolites) should not cause false positives at relevant concentrations, demonstrating assay specificity. | All listed structurally related compounds (e.g., 6-Acetyl Morphine, Amphetamine, Morphine, Fentanyl, etc.) were negative at the high concentrations tested (e.g., 10-500 µg/mL), confirming minimal to no cross-reactivity and high specificity for tramadol. |
| Interference (Structurally Unrelated Compounds): High concentrations of common medications/substances should not cause false positive or false negative results with tramadol present at ±25% of the cutoff. | Over 100 structurally unrelated compounds (e.g., Acetaminophen, Alprazolam, Caffeine, Cocaine, Ibuprofen, etc.) at very high concentrations (up to 500,000 ng/mL) did not yield false results (i.e., remained Negative at 75 ng/mL tramadol and Positive at 125 ng/mL tramadol). This indicates robust resistance to interference. |
| Interference (Endogenous Substances): High concentrations of common endogenous urine components should not cause false positive or false negative results. | All listed endogenous substances (e.g., Acetone, Bilirubin, Creatinine, Glucose, Hemoglobin, Urea, etc.) at physiological or high concentrations did not cause interference, maintaining expected negative or positive results at ±25% of the cutoff. |
| Interference (Specific Gravity and pH): Assay performance should be stable across a wide range of specific gravity and pH values expected in human urine. | No interference was observed across specific gravity values from 1.000 to 1.030 and pH values from 3.0 to 11.0, demonstrating robustness to variations in urine characteristics. |
| Interference (Boric Acid): The assay should either not be interfered with by common preservatives, or any interference should be clearly identified and communicated. | 1% w/v Boric Acid did interfere by causing a negative result at 125 ng/mL in the qualitative mode (expected positive). This is explicitly noted, and a warning is provided: "Boric acid interferes with results from this device. Do not test samples that have boric acid as a preservative." This demonstrates that the interference was identified and addressed with a clear instruction. |
| Method Comparison with Confirmatory Method (LC-MS/MS): A high degree of concordance with the gold standard confirmatory method (LC-MS/MS) for samples far from the cutoff, and clear explanation of discordant results near the cutoff, demonstrating clinical utility. | Concordant Results: |
- 50 samples with LC-MS/MS 150 ng/mL were Positive.
- 4 samples with LC-MS/MS 100-150 ng/mL were Positive.
Discordant Results: - 5 samples with LC-MS/MS 50-99 ng/mL were shown as Positive by the ARK Immunoassay but were Negative by LC-MS/MS according to the cutoff. The cause of discordance for these 5 samples was identified as the presence of O-desmethyltramadol, which cross-reacts with the assay. This provides a clear explanation for expected discrepancies. |
| Calibration Curve Stability: Calibration should remain stable for a reasonable period. | A stored calibration curve was effective for at least 30 days. |
2. Sample Size Used for the Test Set and the Data Provenance
- Precision Studies: 160 determinations for each of 9 concentration levels (0.0 to 200.0 ng/mL) for both qualitative and semiquantitative modes. This totals 160 * 9 = 1440 individual measurements across 20 days. The samples were
- Data Provenance: Drug-free, negative human urine that was spiked with tramadol to create the test concentrations. The geographic origin of the human urine or whether it was retrospective/prospective is not specified beyond "human urine."
- Analytical Recovery: Not explicitly stated, but "N=6" is mentioned for the mean concentration calculation at each of the 11 tested levels. So, 6 samples for each of 11 concentrations (50.0 to 1000.0 ng/mL) were used. These were also dilutions from drug-free, negative human urine spiked with tramadol.
- Analytical Specificity (Metabolites and Structurally Related Compounds): Not explicitly stated, but compounds were "spiked into drug-free, negative human urine." The number of samples per compound is not specified, but each compound was tested.
- Interference (Structurally Unrelated Compounds & Endogenous Substances): Not explicitly stated for each concentration or substance, but involved "High concentrations of the following structurally unrelated compounds/endogenous substances were added into urine spiked with tramadol (± 25% of the cutoff concentration) and tested."
- Interference (Specific Gravity, pH, Boric Acid): Samples were spiked urine (± 25% of cutoff) manipulated for specific gravity/pH or with boric acid added. The number of samples is not explicitly stated per condition.
- Method Comparison: A total of 115 unaltered clinical human urine specimens.
- Data Provenance: "clinical human urine specimens that are not individually identifiable." No country of origin is specified, but "unaltered clinical human urine specimens" suggests real-world samples. Whether retrospective or prospective is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This is an in vitro diagnostic (IVD) device for chemical analysis, not an imaging or clinical interpretation device. Therefore, the concept of "experts" establishing ground truth in the way a radiologist would for an image is not applicable.
- For the method comparison study, the ground truth was established by a "licensed reference laboratory" using Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS), which are considered the gold standard confirmatory methods for drug testing. The qualifications of the personnel performing these confirmatory tests are inherent to the "licensed reference laboratory" performing a gold-standard chemical analysis, rather than subjective expert opinion.
4. Adjudication Method for the Test Set
- Not applicable as this is a chemical assay with objective measurements (spectrophotometric absorbance changes) and comparison to a definitive analytical method (LC-MS/MS) for ground truth. Discrepancies in the method comparison were analytically explained (e.g., cross-reactivity with O-desmethyltramadol) rather than requiring human adjudication of subjective interpretations.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study design is typically used for medical imaging devices or other diagnostic tools where human interpretation plays a significant role. The ARK Tramadol Assay is an automated immunoassay for chemical analysis, not a device requiring human "readers" in the context of an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, this entire study represents a standalone performance evaluation. The ARK Tramadol Assay is an automated immunoassay performed on "automated clinical chemistry analyzers." Its performance is directly compared to an established analytical method (LC-MS/MS), without "human-in-the-loop" interpretation as a primary output of the device itself. The results are quantitative (in semiquantitative mode) or qualitative (positive/negative), derived directly from the instrument's measurements.
7. The Type of Ground Truth Used
- The ground truth used was confirmatory analytical methods, specifically Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS), which are considered the gold standard for drug detection and quantification in biological samples.
8. The Sample Size for the Training Set
- The document does not provide information about a "training set" in the context of machine learning or AI. This device is an immunoassay, whose performance is based on established biochemical principles and reagents, not a machine learning algorithm that is "trained" on data. The studies described are method development and validation studies to establish the assay's analytical performance.
9. How the Ground Truth for the Training Set Was Established
- As noted in point 8, there is no "training set" in the context of this immunoassay. The concept of "ground truth for a training set" is therefore not applicable. The assay's design and reagents are based on antibody-antigen binding principles rather than data-driven machine learning.
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(51 days)
ARK Diagnostics, Inc.
The ARK EDDP Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of EDDP in human urine at cutoff concentrations of 100 ng/mL and 300 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 semiquantitative 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 EDDP 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 EDDP Assay is a homogeneous enzyme immunoassay technique used for the analysis of EDDP in human urine. The assay is based on competition between EDDP in the specimen and EDDP labeled with recombinant glucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. As the latter binds antibody, enzyme activity decreases. In the presence of EDDP from the specimen, enzyme activity increases and is directly related to the EDDP 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 EDDP Assay consists of reagents R1 anti-EDDP rabbit antibody with substrate and R2 EDDP derivative labeled with bacterial recombinant G6PDH enzyme.
Here's a breakdown of the acceptance criteria and study details for the ARK EDDP Assay, based on the provided FDA 510(k) summary:
This document describes a medical device, the ARK EDDP Assay, which is an immunoassay for the qualitative and/or semi-quantitative determination of EDDP (a methadone metabolite) in human urine. The study presented is a non-clinical performance evaluation, as indicated by "Brief Description of Nonclinical and Clinical Data" and the nature of the tests (Precision, Analytical Recovery, Analytical Specificity, Interference, etc.). No clinical study involving human patients or human readers in an MRMC setting is described.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" as a single, consolidated table with specific pass/fail values for each performance characteristic. Instead, performance is evaluated against expected behaviors for an in vitro diagnostic (IVD) device of this type. The inferred acceptance criteria are that the device should demonstrate acceptable precision, accurate analytical recovery, appropriate cross-reactivity and interference profiles, and good agreement with a gold standard (GC/MS) in method comparison for qualitative and semi-quantitative results.
| Performance Characteristic | Inferred Acceptance Criteria (Implicit) | Reported Device Performance and Discussion |
|---|---|---|
| Precision | Consistent qualitative and semi-quantitative results, particularly around the cutoff concentrations. | 100 ng/mL Cutoff: |
| - Qualitative (100 ng/mL) | All samples ≤ 75 ng/mL should be negative; all samples ≥ 125 ng/mL should be positive. Samples at 100 ng/mL (cutoff) may show mixed results. | At 0.0, 25.0, 50.0, and 75.0 ng/mL, all 160 results were Negative. At 125.0, 150.0, 175.0, and 200.0 ng/mL, all 160 results were Positive. At the 100.0 ng/mL cutoff, 123 were Negative and 37 were Positive, which is expected for a cutoff concentration. |
| - Semiquantitative (100 ng/mL) | Mean measured concentrations should be close to theoretical values. Expected mixed qualitative results at cutoff. | Mean concentrations were close to theoretical (e.g., 98.1 ng/mL for 100 ng/mL theoretical). At 100.0 ng/mL cutoff, 114 were Negative and 46 were Positive, consistent with a cutoff. |
| - Qualitative (300 ng/mL) | All samples ≤ 225 ng/mL should be negative; all samples ≥ 375 ng/mL should be positive. Samples at 300 ng/mL (cutoff) may show mixed results. | At 0.0, 75.0, 150.0, and 225.0 ng/mL, all 160 results were Negative. At 375.0, 450.0, 525.0, and 600.0 ng/mL, all 160 results were Positive. At the 300.0 ng/mL cutoff, 57 were Negative and 103 were Positive, which is expected. |
| - Semiquantitative (300 ng/mL) | Mean measured concentrations should be close to theoretical values. Expected mixed qualitative results at cutoff. | Mean concentrations were close to theoretical (e.g., 298.8 ng/mL for 300 ng/mL theoretical). At 300.0 ng/mL cutoff, 85 were Negative and 75 were Positive, consistent with a cutoff. |
| Analytical Recovery | Measured concentration should be within an acceptable percentage range of the theoretical concentration. | Recovery percentages ranged from 94.6% to 107.9% across EDDP concentrations from 50.0 to 1000.0 ng/mL, indicating good analytical recovery. |
| Analytical Specificity | Minimal to no cross-reactivity with structurally related and unrelated compounds, ensuring specificity for EDDP. | Structurally Related Compounds: EDDP showed 100% cross-reactivity (as expected). Methadone and EMDP showed very low cross-reactivity ( |
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(110 days)
ARK Diagnostics, Inc.
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 ( |
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(261 days)
ARK Diagnostics, Inc.
The ARK™ Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of methotrexate to help ensure appropriate therapy.
Specimens from patients who have received glucarpidase (carboxypeptidase G2) as a high dose methotrexate rescue therapy should not be tested with the ARK Methotrexate Assay.
The ARK Methotrexate Assay is a homogeneous immunoassay based on competition between drug in the specimen and Methotrexate labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. 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 the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Methotrexate Assay consists of reagents R1 anti-Methotrexate polyclonal antibody with substrate and R2 Methotrexate labeled with bacterial G6PDH enzyme. The ARK Methotrexate Calibrator consists of a six-level set to calibrate the assay, and the ARK Methotrexate Control consists of a six-level set used for quality control of the assay (tri-level calibration range set and tri-level high range set). The ARK Methotrexate Dilution Buffer is equivalent to zero calibrator (Calibrator A).
Here's an analysis of the provided text to extract the acceptance criteria and study information:
Acceptance Criteria and Device Performance for ARK™ Methotrexate Assay
The provided document describes the acceptance criteria and the study that proves the ARK™ Methotrexate Assay, when used on the Beckman Coulter AU680 analyzer, meets these criteria. The study aims to demonstrate substantial equivalence to the assay's performance on the predicate device, the Roche/Hitachi 917 analyzer.
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The pre-determined Pass/Fail acceptance criteria were met for all of the above performance studies." However, the specific numerical acceptance criteria or performance values for each characteristic are not provided in the given text. It only lists the types of performance characteristics evaluated.
| Performance Characteristic | Acceptance Criteria (Not Detailed) | Reported Device Performance |
|---|---|---|
| Limit of Blank | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Limit of Detection | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Limit of Quantitation | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Recovery | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Linearity | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Accuracy (Method Comparison) | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Precision | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Specificity | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Cross-reactivity | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Carry-over | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Dilution Recovery | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| On-board Stability | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the test set for any of the performance studies.
The document refers to "human serum or plasma" as the sample type. The country of origin of the data is not explicitly stated. The study is a "validation and verification" activity, implying it was conducted specifically for this submission, likely making it a prospective study for the purpose of device validation.
3. Number of Experts and Qualifications for Ground Truth
The concept of "experts" and their qualifications for establishing ground truth, as typically seen in image analysis or diagnostic interpretation, is not applicable to this type of in vitro diagnostic device (immunoassay) study. The ground truth for this device's performance characteristics is established through analytical methods and reference standards, not expert interpretation.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable to this type of in vitro diagnostic device (immunoassay) study. Performance is assessed through quantitative measurements against established analytical criteria, not through expert consensus on diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of in vitro diagnostic device (immunoassay). This study design is typically used for imaging or diagnostic interpretation tasks where human readers' performance is being evaluated, often with and without AI assistance. This device is an automated assay, not an AI for human interpretive tasks.
6. Standalone (Algorithm Only) Performance Study
The study described is a standalone performance study for the algorithm (assay system) on the Beckman Coulter AU680 analyzer. The validation and verification activities listed (Limit of Blank, Limit of Detection, Accuracy, Precision, etc.) directly evaluate the performance of the device itself, without human interpretation in the loop. The purpose is to demonstrate that the assay system alone performs comparably to its predicate.
7. Type of Ground Truth Used
For an immunoassay like the ARK™ Methotrexate Assay, the "ground truth" for evaluating its performance characteristics (analytical accuracy, precision, linearity, etc.) would be established through:
- Reference materials/standards: Calibrators and controls with precisely known concentrations of methotrexate.
- Reference methods: Comparison with established, validated analytical methods (e.g., LC-MS/MS, or the predicate device's performance which was previously validated) for samples with unknown concentrations.
- Spiking studies: Adding known amounts of analyte to a sample and measuring recovery to assess accuracy.
The document implicitly refers to these as part of the "analytical performance studies" and "validation and verification activities."
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This is expected as the ARK™ Methotrexate Assay is a homogeneous enzyme immunoassay kit, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for such a system would involve validating its components and establishing its operational parameters on the target analyzer.
9. How Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of machine learning, this question is not applicable. The assay is a chemical and biological system where parameters are set based on chemical principles and reagent characteristics, and then validated through performance studies.
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(294 days)
ARK DIAGNOSTICS, INC
The ARK Voriconazole II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of voriconazole in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of voriconazole to help ensure appropriate therapy. The assay should only be used in conjunction with information available from clinical evaluations and other diagnostic procedures.
ARK Voriconazole II Calibrator is intended for use in calibration of the ARK Voriconazole II Assay.
ARK Voriconazole II Control is an assayed quality control material intended for use in quality control of the ARK Voriconazole II Assay.
The ARK Voriconazole II Assay Test System consists of the ARK Voriconazole II Assay, the ARK Voriconazole II Calibrator, and the ARK Voriconazole II Control.
The ARK Voriconazole II Assay consists of:
- Reagent R1: rabbit polyclonal antibodies to voriconazole, glucose-6-phosphate, nicotinamide adenine dinucleotide, bovine serum albumin, sodium azide, and stabilizers.
- Reagent R2: voriconazole labeled with bacterial G6PDH buffer, bovine serum albumin, sodium azide, and stabilizers.
The ARK Voriconazole II Calibrator has six levels and consists of voriconazole, buffer, bovine serum albumin, and sodium azide.
The ARK Voriconazole II Control has three levels and consists of voriconazole, buffer, bovine serum albumin, and sodium azide.
Here's a breakdown of the acceptance criteria and the study details for the ARK Voriconazole II Assay Test System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the special controls and the types of studies performed, aiming for performance characteristics that make the device fit for its intended use. Specific numerical acceptance criteria were not explicitly stated in all sections (e.g., for precision, rather than a universal requirement, the reported values are provided). However, for interference studies, a clear threshold was defined.
| Performance Characteristic | Acceptance Criteria (Implied/Explicit) | Reported Device Performance |
|---|---|---|
| Precision (Internal) | Not explicitly stated (demonstrate precision) | Total CV% for controls: LOW (4.9), MID (4.3), HIGH (4.5). Total CV% for human serum: LOW (4.6), MID (4.3), HIGH (4.2). Second internal study Total CV%: LOW (5.9), MID (5.1), HIGH (6.3). |
| Precision (Multi-Site) | Not explicitly stated (demonstrate precision) | Reproducibility CV% for controls: LOW (6.0), MID (5.5), HIGH (6.5). Reproducibility CV% for human serum: LOW (5.4), MID (5.2), HIGH (5.5). |
| Linearity/Reportable Range | Claimed measuring range (0.5 to 14.0 ug/mL) supported by regression. | Y = 1.0209 X - 0.0416, R²: 0.9995. Supports range 0.5 to 14.0 ug/mL. |
| Analytical Recovery | Not explicitly stated (assess recovery). | Ranged from 90.0% to 104.9%. |
| Traceability | Calibrators traceable to certified standard. | Calibrators traceable to USP Reference Standard. |
| Detection Limit | LoB, LoD, LoQ determined per CLSI EP17-A2. LoQ bias ≤15% and within-lab precision ≤10%. | LoB = 0.003 ug/mL. LoD = 0.05 ug/mL. LoQ = 0.5 ng/mL (0.0005 ug/mL). Note: The text states 0.5 ng/mL but the linear range is 0.5 ug/mL, implying a discrepancy or typo in the LoQ value in the document. Assuming it meant 0.5 ug/mL for consistency with the linear range. |
| Analytical Specificity (Endogenous Substances) | Interference considered significant if analytical recovery is outside of ± 10% of initial value. | All reported percentage recoveries for endogenous substances at 1.0 µg/mL and 5.0 µg/mL voriconazole were within 90-110%. |
| Cross-reactivity (N-oxide Voriconazole) | Data from studies performed to evaluate cross-reactivity. | Non-significant (≤ 3.0%) cross-reactivity observed. |
| Potentially Co-Administered Medications | Data from interference studies. Interference considered significant if analytical recovery is outside of ± 10% of initial value. | No significant interference observed. All reported percentage recoveries were within the 90-110% range. |
| Method Comparison (Accuracy) | Data demonstrating accuracy; comparator method not subject to bias. | Passing Bablok regression slope 0.98-0.99 (95% CI covering 1), intercept 0.05-0.08 (95% CI covering 0), R² 0.95-0.97. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision (Internal Study 1): 160 replicates for each of 3 control levels and 3 human serum pools. Likely internal ARK data.
- Precision (Internal Study 2): 120 replicates for each of 3 patient sample pools. Likely internal ARK data.
- Precision (Multi-Site Study): 120 replicates for each of 3 control levels and 3 human serum pools across 3 sites (360 total per control/pool level). Data from ARK and two external sites.
- Linearity: 11 levels of samples, tested in two runs with three replicates per run. Samples were prepared by dilution of pure voriconazole in pooled human serum.
- Analytical Recovery: Serum samples prepared by gravimetric and volumetric addition of pure voriconazole to human serum. Number of samples not explicitly stated but covers 7 concentration points.
- Detection Limit Studies:
- LoB: 20 blank patient specimens tested.
- LoD/LoQ: A low concentration pooled serum sample.
- Analytical Specificity (Endogenous Substances): Samples with known levels of voriconazole (1 and 5 ug/mL) spiked with interferents. Each sample tested in two runs with three replicates per run.
- Cross-reactivity: N-oxide-voriconazole at 5.0 ug/mL and 10.0 µg/mL levels, tested in absence or presence of voriconazole.
- Potentially Co-Administered Medications: Samples with known levels of voriconazole (1 and 5 ug/mL) spiked with 58 different medications.
- Method Comparison Study: 165 serum specimens. Samples represented a diverse population of in-hospital patients. Tested at 3 study sites. Provenance is prospective in the sense that they are patient samples collected for comparison, likely from the hospitals where the sites were located. Origin (country) not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is an in-vitro diagnostic test for measuring an analyte (voriconazole concentration) in human serum. The "ground truth" for these studies is established through either:
- Known gravimetric/volumetric preparation of standards (for linearity, recovery, detection limits, interference, cross-reactivity).
- Comparison with a reference method (LC-MS/MS for the method comparison study).
The concept of "experts" to establish ground truth as typically found in image analysis or clinical diagnosis contexts (e.g., radiologists, pathologists) does not apply here.
4. Adjudication Method for the Test Set
- Not Applicable. As explained above, ground truth is established through analytical means or comparison to a reference method, not through human expert adjudication.
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
- Not Applicable. This is an in-vitro diagnostic device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation device that involves human "readers."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this is a standalone device validation. The ARK Voriconazole II Assay Test System is an automated clinical chemistry analyzer-based test. The performance characteristics described are for the device (the assay and analyzer) itself, without human intervention in the measurement process once the sample is loaded. The "algorithm" here is the chemical reaction and spectrophotometric measurement programmed into the analyzer.
7. The Type of Ground Truth Used
- Known concentrations: For precision, linearity, analytical recovery, detection limits, endogenous substance interference, cross-reactivity, and co-administered medication interference studies, the "ground truth" was either:
- Gravimetrically/volumetrically prepared samples with known concentrations of voriconazole or interferents.
- Pooled human serum samples with established mean concentrations.
- Reference method (LC-MS/MS): For the method comparison study, the validated LC-MS/MS method served as the reference standard for establishing the ground truth concentrations in patient samples.
8. The Sample Size for the Training Set
- Not Applicable. This is an in-vitro diagnostic assay based on a homogeneous enzyme immunoassay principle, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of the device involves calibration using the provided ARK Voriconazole II Calibrators.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, it's not an AI/ML training set. The "ground truth" for the calibrators (which serve a similar function to training in some contexts, by enabling the device to accurately convert signal into concentration) is established through internal procedures and traceability to a certified USP Reference Standard. The text states: "The ARK Voriconazole II Calibrators are traceable to a certified USP Reference Standard." and "Concentrations of the ARK Voriconazole II Calibrators and Controls are assigned through internal procedures that were reviewed and found to be acceptable."
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