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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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