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510(k) Data Aggregation
(193 days)
California 94538
Re: K232522
Trade/Device Name: ARK Levetiracetam II Assay Regulation Number: 21 CFR 862.3350
Homogeneous Enzyme Immunoassay |
| Classification: | 21 CFR 862.3350
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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(69 days)
Trade/Device Name: ONLINE TDM Phenytoin - Free Phenytoin application Regulation Number: 21 CFR 862.3350
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| Product Codes, Regulation Numbers | MOJ, 862.3350
The ONLINE TDM Phenytoin - Free Phenytoin application is an in vitro test for the quantitative determination of free phenytoin in human serum and plasma on cobas c systems. The determination of free phenytoin is used in monitoring levels of free phenytoin to ensure appropriate therapy.
The ONLINE TDM Phenytoin - Free Phenytoin application is an in vitro test for the quantitative determination of free phenytoin in human serum and plasma on cobas c systems. The determination of free phenytoin is used in monitoring levels of free phenytoin to ensure appropriate therapy.
Prior to measurement using the ONLINE TDM Phenytoin - Free Phenytoin application, the sample is processed by ultrafiltration to remove the bound phenytoin generating a result for free phenytoin.
The ONLINE TDM Phenytoin - Free Phenytoin application is based on the kinetic interaction of microparticles in a solution (KIMS). Phenytoin antibody is covalently coupled to microparticles and the drug derivative is linked to a macromolecule. The kinetic interaction of microparticles in solutions, photometrically detected by turbidity measurements is induced by binding of drugconjugate to the antibody on the microparticles and is inhibited by the presence of phenytoin in the sample. A competitive reaction takes place between the drug conjugate and phenytoin in the serum sample for binding to the phenytoin antibody on the microparticles. The resulting turbidity is indirectly proportional to the amount of drug present in the sample.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: ONLINE TDM Phenytoin - Free Phenytoin application
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Precision | Implicit: Acceptable repeatability and intermediate precision, likely defined by a maximum allowable Coefficient of Variation (CV%) or Standard Deviation (SD) as per CLSI EP05-A3. (No specific numerical criteria for CV% or SD are explicitly stated as "acceptance criteria" in the text, but the claim "All acceptance criteria were met" implies adherence to predefined thresholds.) | Repeatability (CV%): |
- 2.2% - 2.9% for Control 1, Control 2, and Human Serums 1-5
Intermediate Precision (CV%): - 2.8% - 3.5% for Control 1, Control 2, and Human Serums 1-5 |
| Analytical Sensitivity | Implicit: LoB, LoD, and LoQ determined according to CLSI EP17-A2, and likely within a range consistent with the intended clinical use. (No specific numerical criteria are explicitly stated for these limits as "acceptance criteria"). | LoB: 0.100 µg/mL (0.396 µmol/L)
LoD: 0.200 µg/mL (0.792 µmol/L)
LoQ: 0.400 µg/mL (1.58 µmol/L) |
| Linearity/Reportable Range | Linearity confirmed for the measuring range of 0.400-4.00 µg/mL (1.58-15.8 µmol/L) per CLSI EP06-A-Ed2. | Confirmed for the measuring range of 0.400-4.00 µg/mL (1.58-15.8 µmol/L). |
| Dilution | Automatic rerun function (1:2 dilution) for samples above measuring range should demonstrate acceptable deviation. (Exact % deviation acceptance criteria not stated, but "All acceptance criteria were met" implies compliance). | Demonstrated % deviation results of -7.3% to -11.6% when using the automatic rerun function for samples above the measuring range. |
| Endogenous Interferences | No significant interference at specified concentrations for various endogenous substances (e.g., Hemolysis, Icterus, Triglycerides, Albumin, Total protein, Rheumatoid factors, Immunoglobulin G). (Specific acceptance criteria for "no interference up to" certain levels are explicitly stated in the claims summary, e.g., H index of 1000 for Hemolysis). | All predefined acceptance criteria were met. Specific claims are: - Hemolysis: No interference up to H index of 1000
- Icterus: I index of 60 for conjugated bilirubin
- Triglycerides: 700 mg/dL
- Albumin: 60 g/L
- Total protein: between 2-12 g/dL
- Rheumatoid factors: 1200 IU/mL
- Lipemia: L index of 1000
- Immunoglobulin G: 60 g/L
– No significant phenytoin release for conjugated bilirubin up to 18 mg/dL, unconjugated bilirubin up to 9 mg/dL, triglycerides up to 183 mg/dL, and rheumatoid factors up to 284 IU/mL. |
| Analytical Specificity/Cross-Reactivity | Acceptable cross-reactivity for tested compounds (e.g., Fosphenytoin ≤ 50.0 %, m-HPPH ≤ 10.0 %). (Specific numerical criteria for % Cross Reactivity are explicitly stated in the table). | All acceptance criteria for cross-reactivity were met. Specific values reported: - Fosphenytoin: ≤ 50.0 %
- m-HPPH: ≤ 10.0 %
- p-HPPH: ≤ 5.0 %
- 5(p-methylphenyl)-5-phenylhydantoin: ≤ 5.0 % |
| Exogenous Interferences (Drugs) | No increase in free phenytoin concentrations at tested concentrations for commonly used pharmaceuticals, or expected increases for drugs that compete for albumin binding (e.g., Valproic acid).
For phenobarbital and mephenytoin, analytical interference starts above specific concentrations (e.g., >90 µg/mL for phenobarbital in ultrafiltrate). | No increase in free phenytoin concentrations observed for a long list of tested drugs.
Increased concentrations observed for Butabarbital, Carbamazepine, Cefoxitin, Ethotoin, p-Hydroxyphenobarbital, Ibuprofen, Oxaprozine, Phenylbutazone, d-Propoxyphene, and Valproic acid when spiked into serum (due to competition for albumin binding). These did not show analytical interference in ultrafiltrate.
Phenobarbital and Mephenytoin showed significant increase above 34.5 µg/mL and 40.0 µg/mL respectively in serum, and analytical interference above 90 µg/mL (phenobarbital) and 60 µg/mL (mephenytoin) in ultrafiltrate. |
| Sample Matrix Comparison | Acceptable correlation/agreement between serum and various plasma types (Li-Heparin, K2-EDTA, K3-EDTA plasma). (No specific numerical criteria for slope, intercept, or correlation coefficient are stated as "acceptance criteria"). | All predefined acceptance criteria were met. - Serum vs. Li-Heparin plasma: Slope 1.018, Intercept -0.0149, r 0.988
- Serum vs. K2-EDTA plasma: Slope 0.923, Intercept -0.0328, r 0.992
- Serum vs. K3-EDTA plasma: Slope 0.950, Intercept -0.0282, r 0.992 |
| Method Comparison | Acceptable agreement with the predicate device (Phenytoin - Free Phenytoin Application on COBAS INTEGRA 400 plus). (No specific numerical criteria for Passing/Bablok or Deming regression parameters are stated as "acceptance criteria"). | Passing/Bablok: y = 1.035x - 0.0165 µg/mL, τ = 0.972
Deming Regression: y = 1.019x + 0.0107 µg/mL, r = 0.998 |
| Stability | Implicit: Data supports Roche Diagnostic's claims as reported in the package labeling. (No specific criteria are detailed in this section.) | Stability data supports claims as reported in package labeling. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision (Repeatability and Intermediate Precision):
- Repeatability: n = 84 (implied total measurements, as 2 aliquots per run, 2 runs per day, 21 days = 84 measurements for intermediate precision, and repeatability likely collected within this structure).
- Intermediate Precision: 2 aliquots per run, 2 runs per day, 21 days.
- Data Provenance: Not explicitly stated, implied to be laboratory-prepared controls and human serum samples.
- Analytical Sensitivity (LoB, LoD, LoQ):
- LoB: One analyte-free sample (ultrafiltrate of human phenytoin-free serum) measured with three reagent lots in 6 runs, each with 10-fold determination (total 180 measurements).
- LoD: 5 serum samples with low analyte concentrations (spiked with phenytoin and ultrafiltrated) measured on three reagent lots with 2-fold determination per run, over 6 runs (total 180 measurements).
- LoQ: 6 serum samples (spiked with phenytoin and ultrafiltrated) measured with three reagent lots, 5 replicates per run, over 5 days (total 450 measurements).
- Data Provenance: Human phenytoin-free serum, spiked human serum samples (ultrafiltrated).
- Linearity/Assay Reportable Range:
- Sample Size: A dilution series ( > 9 levels) prepared from a spiked human ultrafiltrated serum pool and a negative ultrafiltrated serum pool. Tested with 3 reagent lots and 4 replicates per sample. The process was repeated with K3-EDTA plasma.
- Data Provenance: Spiked human ultrafiltrated serum pool and negative ultrafiltrated serum pool, K3-EDTA plasma.
- Dilution:
- Sample Size: Three ultrafiltrates prepared with specific phenytoin concentrations (5.00, 6.00, 7.00 µg/mL).
- Data Provenance: Laboratory-prepared ultrafiltrates with spiked phenytoin.
- Endogenous Interferences:
- Sample Size: Not explicitly stated, but various endogenous substances were evaluated. The description suggests samples were prepared by adding interferents to ultrafiltrate or present in the sample before ultrafiltration.
- Data Provenance: Laboratory-prepared samples with added endogenous substances or naturally occurring levels.
- Analytical Specificity/Cross-Reactivity:
- Sample Size: Two ultrafiltrated human serum pools spiked with phenytoin (1.00 and 2.50 µg/mL) for each potential cross-reacting compound. Phenytoin concentration determined in at least 5-fold determination.
- Data Provenance: Ultrafiltrated human serum pools spiked with phenytoin and cross-reactants.
- Exogenous Interferences - Drugs:
- Sample Size: Not explicitly stated, but drugs were tested individually at specified concentrations. Some drugs were tested by spiking into serum, others into ultrafiltrate.
- Data Provenance: Laboratory-prepared samples with added drugs.
- Sample Matrix Comparison:
- Sample Size: ≥ 50 samples comparing serum, Li-Heparin, K2-EDTA, and K3-EDTA plasma.
- Data Provenance: Native human samples collected in different tube types, spiked and ultrafiltrated.
- Method Comparison:
- Sample Size: 138 native human ultrafiltrated serum samples (≤10% spiked).
- Data Provenance: Native human ultrafiltrated serum samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device is an in vitro diagnostic (IVD) test system for the quantitative determination of free phenytoin. The "ground truth" for such a device is typically established by reference methods or established analytical techniques, often involving highly skilled laboratory personnel operating calibrated equipment, rather than clinical experts (like radiologists).
The text does not mention the use of clinical experts (e.g., radiologists) or their qualifications to establish ground truth. The methodologies like CLSI guidelines (EP05-A3, EP17-A2, EP06-A-Ed2) imply adherence to established laboratory standards and practices for analytical validation, often performed by trained laboratory scientists or technicians.
4. Adjudication Method for the Test Set
This type of analytical device validation does not typically involve an "adjudication method" in the way it's understood for image-based diagnostics (e.g., 2+1, 3+1 consensus among radiologists). Results are quantitative and are compared directly to expected values, reference methods, or statistical acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for AI-powered diagnostic devices where human readers interpret images or data, and the study assesses how AI assistance impacts their performance. This submission is for an in vitro diagnostic (IVD) laboratory test system, not an image-interpretation AI device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is a standalone in vitro diagnostic test system. Its performance characteristics (precision, sensitivity, linearity, interference, etc.) are evaluated directly as the device itself operates. There isn't a separate "human-in-the-loop performance" concept for this type of quantitative assay, as the device provides a direct numerical result. The reported performance is the standalone performance of the ONLINE TDM Phenytoin - Free Phenytoin application on cobas c systems.
7. The Type of Ground Truth Used
The ground truth for the analytical performance studies primarily relied on:
- Reference Materials: Calibrators (Preciset TDM I), Controls (TDM Control Set), and laboratory-prepared samples with known concentrations of phenytoin and/or interferents (e.g., spiked serum, ultrafiltrates).
- Established Methods: Comparison to a predicate device (Phenytoin - Free Phenytoin Application on COBAS INTEGRA 400 plus) in the method comparison study.
- Theoretical Standards: Adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines (EP05-A3, EP17-A2, EP06-A-Ed2) for defining analytical limits and linearity.
There is no mention of pathology, outcomes data, or expert consensus in the clinical sense for establishing ground truth for this analytical performance.
8. The Sample Size for the Training Set
The document does not describe a "training set" as would be relevant for a machine learning or AI-based device. This device is a chemical assay (Kinetic Interaction of Microparticles in a Solution - KIMS). The development of the assay itself would involve optimization and calibration phases, but these are not referred to as statistical "training sets" in the context of general device validation.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" described in the context of an AI/ML algorithm, this question is not applicable. The assay's performance is driven by its chemical and optical principles, not by learning from a labeled dataset. The "ground truth" during assay development would be established through careful analytical chemistry techniques to ensure the reagents and measurement system accurately quantify free phenytoin.
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(469 days)
Boulevard Fremont, CA 94538
Re: K201089
Trade/Device Name: ARK Lacosamide Assay Regulation Number: 21 CFR 862.3350
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| NWM | Class II | 862.3350
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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(169 days)
|
| Classification: | 21 CFR 862.3350
Gabapentin Assay, ARK™ Gabapentin Calibrator, and ARK™ Gabapentin Control Regulation Number: 21 CFR 862.3350
The ARK™ Gabapentin Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of gabapentin in human serum or plasma on automated clinical chemistry analyzers. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.
The ARKTM Gabapentin Calibrator is intended for use in calibration of the ARK Gabapentin Assay.
The ARKTM Gabapentin Control is intended for use in quality control of the ARK Gabapentin Assay.
The ARK Gabapentin Assay is a homogeneous immunoassay based on competition between drug in the specimen and gabapentin 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 coenyzme NAD functions only with the bacterial enzyme used in the assay.
The ARK Gabapentin Assay consists of reagents R1 anti-gabapentin polyclonal antibody with substrate and R2 gabapentin labeled with bacterial G6PDH enzyme. The ARK Gabapentin Calibrator consists of a six-level set to calibrate the assay, and the ARK Gabapentin Control consists of a three-level set used for quality control of the assay.
ARK Gabapentin products contain ≤0.09% sodium azide. As a precaution, affected plumbing should be flushed adequately with water to mitigate the potential accumulation of explosive metal azides. No special handling is required regarding other assay components.
Here's a summary of the acceptance criteria and study findings for the ARK™ Gabapentin Assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LOQ) | ≤20% CV with ±15% recovery | 0.75 µg/mL (demonstrated acceptable inter-assay precision and recovery) |
| Recovery / Accuracy | Not explicitly stated as a defined criterion (implied by typical assay validation standards that recovery should be close to 100% within a certain range). | Mean percent recovery: 100.9% across concentrations from 1.0 to 40.0 µg/mL. |
| Linearity | Percent difference between predicted 1st and 2nd order regressed values of ±10%, or ±15% for concentrations ≤ 1.0 µg/mL. | Linear relationship demonstrated between 0.75 and 48.0 µg/mL. All points met the ±10% or ±15% (for lower concentrations) difference criteria. (e.g., 0.75 µg/mL: 12.0% difference; 1.0 µg/mL: 8.4% difference; all others below 2.2% difference up to 48 µg/mL). |
| Assay Range | Not explicitly stated as an acceptance criterion for the range itself, but the device performance defines the reportable range. | 0.75 to 40.0 µg/mL. |
| Method Comparison (Correlation) | Implied by the use of Passing-Bablok regression: a slope close to 1, y-intercept close to 0, and a high correlation coefficient (r²) indicating strong agreement with reference methods. | Study 1 (LC-MS/MS): Slope 0.96 (0.92 to 0.99), y-intercept -0.06 (-0.28 to 0.18), r² 0.96 (0.95 to 0.97). |
| Study 2 (HPLC): Slope 1.08 (1.03 to 1.13), y-intercept -0.08 (-0.35 to 0.25), r² 0.97 (0.95 to 0.98). | ||
| Study 3 (LC-MS/MS): Slope 1.13 (1.08 to 1.17), y-intercept 0.31 (0.06 to 0.52), r² 0.98 (0.97 to 0.99). | ||
| Precision |
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(172 days)
|
| Classification: | 21 CFR 862.3350
Lamotrigine Assay, ARK™ Lamotrigine Calibrator, and ARK™ Lamotrigine Control
Regulation Number: 21 CFR 862.3350
The ARK™ Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers. Lamotrigine concentrations can be used as an aid in management of patients treated with lamotrigine.
The ARKTM Lamotrigine Calibrator is intended for use in calibration of the ARK Lamotrigine Assay.
The ARKTM Lamotrigine Control is intended for use in quality control of the ARK Lamotrigine Assay.
The ARK Lamotrigine Assay is a homogeneous immunoassay based on competition between drug in the specimen and lamotrigine 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 coenyzme NAD functions only with the bacterial enzyme used in the assay.
The ARK Lamotrigine Assay consists of reagents R1 anti-lamotrigine polyclonal antibody with substrate and R2 lamotrigine labeled with bacterial G6PDH enzyme. The ARK Lamotrigine Calibrator consists of a six-level set to calibrate the assay, and the ARK Lamotrigine Control consists of a three-level set used for quality control of the assay.
The ARK™ Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lamotrigine in human serum or plasma. The device performance was evaluated through various studies, including limit of quantitation (LOQ), assay range, recovery, linearity, method comparison, precision, interfering substances, specificity, and anticoagulant studies.
1. Acceptance Criteria and Reported Device Performance:
| Study/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LOQ) |
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(168 days)
|
| Classification: | 21 CFR 862.3350
name: ARK Zonisamide Assay, Zonisamide Calibrator, ARK Zonisamide Control Regulation Number: 21 CFR 862.3350
The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of zonisamide in human serum or plasma samples on automated clinical chemistry analyzers. Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide.
The ARK™ Zonisamide Calibrator is intended for use in calibration of the ARK Zonisamide Assay.
The ARK™ Zonisamide Control is intended for use in quality control of the ARK Zonisamide Assav.
The ARK Zonisamide Assay is a homogeneous immunoassay based on competition between drug in the specimen and zonisamide 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 coenyzme NAD functions only with the bacterial enzyme used in the assay.
The ARK Zonisamide Assay consists of reagents R1 anti-zonisamide polyclonal antibody with substrate and R2 zonisamide labeled with bacterial G6PDH enzyme. The ARK Zonisamide Calibrator consists of a six-level set to calibrate the assay, and the ARK Zonisamide Control consists of a three-level set used for quality control of the assay.
Here's a breakdown of the acceptance criteria and the study details for the ARK Zonisamide Assay, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Test/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LOQ) | 0.90) with predicate device | r² = 0.93 (0.91 to 0.95 95% CI) |
| Precision (Total CV) |
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(146 days)
|
| Classification: | 21 CFR 862.3350
Levetiracetam Assay, ARK Levetiracetam Calibrators and ARK Levetiracetam Controls Regulation Number: 21 CFR 862.3350
The ARK™ Levetiracetam 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 ARKTM Levetiracetam Calibrator is intended for use in calibration of the ARK Levetiracetam Assay. The ARK™ Levetiracetam Control is intended for use in quality control of the ARK Levetiracetam Assay.
The ARK Levetiracetam 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 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 coenyzme NAD functions only with the bacterial enzyme used in the assay. The ARK Levetiracetam Assay consists of reagents RI anti-levetiracetam polyclonal antibody with substrate and R2 levetiracetam labeled with bacterial G6PDH enzyme. The ARK Levetiracetam Calibrator consists of a six-level set to calibrate the assay, and the ARK Levetiracetam Control consists of a three-level set used for quality control of the assay.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for ARK™ Levetiracetam Assay
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LOQ) | 20% CV with ±15% recovery | 2.0 µg/mL (not explicitly stated if it met the 20% CV & ±15% recovery, but implied as the determined LOQ) |
| Accuracy (Analytical Recovery) | Not explicitly stated, but implied to be acceptable based on percent recovery within reasonable limits. | Range of 94.6% to 105.3% recovery for concentrations 2.0 to 100.0 µg/mL. |
| Linearity | Percent difference ±10% between 1st and 2nd order regressed values, or ±15% below 3.0 µg/mL. | Linear relationship demonstrated between 2.0 and 100.0 µg/mL. All % Differences were within the specified ±10% (for values ≥3.0 µg/mL) and ±15% (for values |
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(115 days)
|
| Classification: | 21 CFR 862.3350
: ARK Topiramate Assay, ARK Topiramate Calibrator, ARK Topiramate Control Regulation Number: 21 CFR 862.3350
The ARK™ Topiramate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.
The ARK™ Topiramate Calibrator is intended for use in calibration of the ARK Topiramate Assav.
The ARKTM Topiramate Control is intended for use in quality control of the ARK Topiramate Assay.
The ARK Topiramate Assay is a homogeneous immunoassay based on competition between drug in the specimen and topiramate epitope 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 coenyzme NAD functions only with the bacterial enzyme used in the assay.
The ARK Topiramate Assay consists of reagents R1 anti-topiramate polyclonal antibody with substrate and R2 topiramate epitope labeled with bacterial G6PDH enzyme. The ARK Topiramate Calibrator consists of a six-level set to calibrate the assay, and the ARK Topiramate Control consists of a three-level set used for quality control of the assay.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LOQ) | ≤20% CV with ±15% recovery | 1.5 µg/mL |
| Accuracy (Analytical Recovery) | Percent recoveries within 10% of theoretical levels | All reported values from 1.5 µg/mL to 55.0 µg/mL were within 10% of theoretical (e.g., 95.6% to 107.1% recovery). Example: 1.5 µg/mL recovered 95.6%, 55.0 µg/mL recovered 107.1%. |
| Linearity | Percent difference ≤ ±10% between predicted 1st and 2nd order regressed values | Demonstrated linearity between 1.2 and 54.0 µg/mL. Max % Difference outside this range was -18.14% at 0.6 µg/mL. All values within 1.2-54.0 µg/mL were within ±10%. |
| Assay Range | Not explicitly stated as acceptance criteria, but defined as output. | 1.5 µg/mL to 54.0 µg/mL |
| Precision (Total CV) |
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(143 days)
Thyroid Stimulating Hormone Test System (21 CFR 862.1690);
Diphenylhydantoin test system (21 CFR 862.3350
VITROS Immunodiagnostic Products TSH Reagent Pack: For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems and VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
VITROS Immunodiagnostic Products TSH Calibrators: For in vitro use in the calibration of the VITROS ECI/ECIQ Immunodiagnostic Systems and VITROS 5600 Integrated System for the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin).
VITROS Chemistry Products PHYT Slides: For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System.
VITROS Chemistry Products Calibrator Kit 9: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950 and 5.1 FS Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT.
VITROS 5600 Integrated System: For use in the in vitro quantitative, semi-quantitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
The VITROS Immunodiagnostic Products TSH assay and VITROS Chemistry Products PHYT assay are intended for use on the VITROS 5600 Integrated System. The VITROS 5600 Integrated System combines the existing VITROS 5,1 FS Chemistry System (K031924) and the VITROS ECi/ECiQ Immunodiagnostic System (K962919) into a single system. All technology, methodologies and analytical methods currently available on the existing two systems are available on the new integrated system.
This is a 510(k) premarket notification for modifications to existing assays (VITROS Immunodiagnostic Products TSH and VITROS Chemistry Products PHYT) to be used with a new integrated system (VITROS 5600 Integrated System). The submission focuses on demonstrating substantial equivalence to previously cleared devices.
Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of a new diagnostic algorithm's performance are not explicitly detailed in the provided text. This is because the submission is for a system modification rather than a new algorithmic diagnostic device with performance metrics like sensitivity, specificity, etc.
However, based on the context of a 510(k) for a laboratory diagnostic system, we can infer the types of performance criteria that would be relevant for demonstrating substantial equivalence for the modified use of the assays on the new system. These would typically include:
- Method Comparison: Showing that results obtained on the new integrated system are comparable to those obtained on the predicate systems.
- Precision: Demonstrating acceptable within-run and between-run variability on the new system.
- Linearity/Analytical Measurement Range: Confirming the ability to accurately measure analytes across a defined range on the new system.
- Interference: Ensuring common interfering substances do not significantly impact results on the new system.
- Stability: Verifying the stability of reagents and calibrators when used with the new system.
- Reference Range: Confirming the appropriate reference intervals for the assays on the new system.
Since the provided text does not contain detailed study results for these specific performance characteristics (as it's a summary document), I cannot fill out all sections. I will address what can be inferred or is explicitly stated:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria for performance metrics (e.g., "TSH bias must be within X%") or report detailed performance data. Instead, the submission relies on the concept of "substantial equivalence" of the modified device to the predicate devices. This implies that the performance on the new combined system is expected to be equivalent to the already cleared separate systems.
| Acceptance Criteria (Inferred from Substantial Equivalence for IVD assays) | Reported Device Performance (Inferred/Not explicitly detailed in summary) |
|---|---|
| Method Comparison: Results from VITROS 5600 Integrated System are comparable to predicate systems (VITROS ECi/ECiQ and VITROS 5,1 FS Chemistry System). | The submission asserts "All technology, methodologies and analytical methods currently available on the existing two systems are available on the new integrated system" and that the "modified devices have the same intended use, fundamental scientific technology and operating principle as the predicate devices." This implies performance equivalence. |
| Precision: Acceptable within-run and between-run precision for TSH and PHYT assays on VITROS 5600. | Not explicitly detailed in the summary. Implied to be equivalent to predicate. |
| Accuracy/Bias: Acceptable accuracy for TSH and PHYT assays on VITROS 5600. | Not explicitly detailed in the summary. Implied to be equivalent to predicate. |
| Analytical Measurement Range: Proper quantification across the defined analytical range for TSH and PHYT on VITROS 5600. | Not explicitly detailed in the summary. Implied to be equivalent to predicate. |
| Interference: No significant interference from common substances when using TSH and PHYT assays on VITROS 5600. | Not explicitly detailed in the summary. Implied to be equivalent to predicate. |
| Reagent/Calibrator Stability: Demonstrated stability when used with VITROS 5600. | The new system uses "reagents, calibrators and controls identical to the VITROS ECi/ECiQ Immunodiagnostic System and VITROS 5,1 FS Chemistry System," implying their established stability carries over. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the summary document. For method comparison studies in IVDs, hundreds of clinical samples are typically used across the analytical range.
- Data Provenance: Not explicitly stated. Assumed to be clinical samples relevant to the intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This is not applicable in the context of this 510(k) for an in vitro diagnostic (IVD) system. For IVDs, "ground truth" is typically established by reference methods, comparison to predicate devices, or spiking studies, not by expert interpretation of images or clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Diagnostic assays like TSH and PHYT use quantitative measurements, and "adjudication" in the sense of resolving discrepancies between human readers is not relevant. The comparison would be between the numerical results of the new system and the predicate system.
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 IVD system for quantitative measurement, not an AI-assisted diagnostic imaging device that involves human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device (VITROS 5600 Integrated System running the TSH and PHYT assays) is a standalone automated system for quantitative measurement. Its performance is evaluated intrinsically through analytical studies (precision, accuracy, method comparison, etc.) as described under point 1.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this type of IVD device, ground truth would typically be established by:
- Reference Methods: Comparison against established, highly accurate analytical methods.
- Predicate Device Comparison: Demonstrating statistical equivalence of results when compared to the existing cleared devices (VITROS ECi/ECiQ and VITROS 5,1 FS Chemistry System) on the same samples.
- Spiked Samples: Using samples with known concentrations of the analyte.
The submission heavily relies on the "substantial equivalence" to predicate devices, indicating that the predicate device's performance effectively serves as the "ground truth" for comparison.
8. The sample size for the training set:
Not applicable in the AI/machine learning sense. For IVD systems, "training" refers to calibration and quality control. The training of the system for measuring TSH and PHYT would involve:
- Calibration: Using the specific calibrators (VITROS Immunodiagnostic Products TSH Calibrators and VITROS Chemistry Products Calibrator Kit 9). The sample sizes for calibration materials are determined by statistical design to ensure accurate curve fitting.
- Quality Control: Regular testing of quality control materials to ensure the system is performing within specifications.
9. How the ground truth for the training set was established:
- Calibrators: The ground truth (assigned value) for the calibrators is established through a rigorous process by the manufacturer, typically involving reference methods, traceability to international standards (if available for TSH), and extensive internal validation studies.
- Quality Control Materials: Similar to calibrators, assigned values for quality control materials are established by the manufacturer through reference methods and internal validation.
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(183 days)
Trade Name: ARCHITECT iPhenytoin Immunoassay Common Name: Diphenylhydantoin test Governing Regulation: 862.3350
1 2008
Re: K080696
Trade/Device Name: Architect iPhenytoin Immunoassay Regulation Number: 21 CFR 862.3350
The ARCHITECT iPhenytoin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenytoin, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of phenytoin to help ensure appropriate therapy.
The ARCHITECT iPhenytoin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of phenytoin in human serum or plasma.
The ARCHITECT iPhenytoin assay is a one-step STAT immunoassay for the quantitative measurement of phenytoin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample, anti-phenytoin coated paramagnetic microparticles, and phenytoin acridinium-labeled conjugate are combined to create a reaction mixture. The antiphenytoin coated microparticles bind to phenytoin present in the sample and to the phenytoin acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of phenytoin in the sample and the RLUs detected by the ARCHITECT i System optics.
The acceptance criteria and study proving device performance are described below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Precision | Substantially equivalent to the AxSYM Phenytoin assay. |
| Linearity | Substantially equivalent to the AxSYM Phenytoin assay. |
| Interferences | Substantially equivalent to the AxSYM Phenytoin assay. |
| Clinical Performance (Correlation to Predicate) | Correlation coefficient of 0.993 with AxSYM Phenytoin assay. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the clinical performance study. It only mentions "non-clinical performance data" and "clinical performance data."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The study compares the ARCHITECT iPhenytoin assay to a legally marketed predicate device (AxSYM Phenytoin assay), implying the predicate's results are used as the reference, rather than independent expert ground truth establishment for a test set in the traditional sense of image analysis or diagnostic interpretation.
4. Adjudication Method
This information is not applicable and not provided in the document. Adjudication methods are typically used in studies involving human interpretation where discrepancies need to be resolved; this study is an analytical performance comparison of an immunoassay.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The ARCHITECT iPhenytoin assay is an in vitro diagnostic device for quantitative measurement of a drug, not a diagnostic imaging or interpretive device that would typically involve human readers.
6. Standalone Performance Study
The entire study described is a standalone performance study in the context of an in vitro diagnostic device. The ARCHITECT iPhenytoin assay's performance (precision, linearity, interferences, and correlation) was evaluated independently and then compared to a predicate device. There is no human-in-the-loop component in the functionality of this immunoassay.
7. Type of Ground Truth Used
The "ground truth" for the clinical performance evaluation was the results obtained from the legally marketed predicate device, the AxSYM Phenytoin assay. The study aimed to demonstrate substantial equivalence by correlating the results of the new device with the predicate.
8. Sample Size for the Training Set
This information is not provided in the document. As an immunoassay, the device relies on chemical and biological reactions rather than machine learning algorithms that typically require dedicated training sets in the computational sense. The "training" for such devices involves assay development and optimization rather than data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of an immunoassay. The development and optimization of the ARCHITECT iPhenytoin assay would involve standard laboratory practices to establish parameters (e.g., reagent concentrations, incubation times) that yield accurate and reproducible results, rather than a "ground truth" derived from a training dataset in the machine learning sense. The performance characteristics (precision, linearity, etc.) are established through validation studies.
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