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510(k) Data Aggregation
(183 days)
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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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Phenytoin is intended for in vitro diagnostic use in the quantitative determination of the phenytoin concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy.
TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981647 Phenytoin assay on T60 Analyzer.
Not Found
The provided document describes a 510(k) submission for a Phenytoin test system and a TDM Calibration set B. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study against specific acceptance criteria. However, we can extract the reported performance of the new device and compare it to the predicate device, which can act as a proxy for acceptance criteria if the aim is to show similar performance.
Here's an analysis based on the provided text, addressing the requested information:
1. A table of acceptance criteria and the reported device performance
Since specific, pre-defined acceptance criteria are not explicitly stated as separate quantifiable thresholds in the document, I will use the predicate device's performance as the benchmark against which the new device's performance is implicitly evaluated for "substantial equivalence." The reported performance of the new device is compared directly to the predicate in "Table 1".
| Attribute | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | For quantitation of phenytoin in human serum or plasma using automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels to ensure proper therapy. | For in vitro diagnostic use in the quantitative determination of the phenytoin concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy. |
| Indication for Use | Same as Intended Use (for predicate). | Phenytoin is intended for quantitative in-vitro diagnostic determination of the phenytoin concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy. |
| Assay Protocol | Uses recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. | Uses recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. |
| Traceability/ Standardization | Not explicitly stated (implied to be acceptable for a legally marketed device). | The calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum. |
| Sample Type | Serum or plasma (Na or Li heparin, Na EDTA) | Serum |
| Reagent Storage | Store CEDIA® Phenytoin II reagents at 2-8 °C. Do not freeze. Refer to box/bottle labels for expiration date. | The unopened reagents are stable at 2...8 °C until the expiration date. DO NOT FREEZE the unopened or reconstituted reagents. |
| Expected Values | Therapeutic range: 10 - 20 µg/ml for adults, 6 - 14 µg/ml for children. | Therapeutic range for adults: 10 - 20 µg/ml or 40 - 79 µmol/l (1,2) |
| Instrument | Roche Hitachi 912 | T60 and DPC T60i, DPC T60i Kusti |
| Measuring Range | Between 0.6 µg/ml and ~40 µg/ml (158.4 µmol/l). | 0.8 - 38 µg/ml (3.2 – 150 µmol/l) |
| Precision (Within run - Level 6.3/8.6 µg/ml) | SD = 0.20, CV(%) = 3.2 | SD = 0.20, CV(%) = 2.4 |
| Precision (Within run - Level 14.8/20.0 µg/ml) | SD = 0.29, CV(%) = 2.0 | SD = 0.32, CV(%) = 1.6 |
| Precision (Within run - Level 26.8 µg/ml) | SD = 0.35, CV(%) = 1.3 | N/A (new device reports only two levels) |
| Precision (Total - Level 6.3/8.6 µg/ml) | SD = 0.32, CV(%) = 5.1 | SD = 0.39, CV(%) = 4.5 |
| Precision (Total - Level 14.8/20.0 µg/ml) | SD = 0.46, CV(%) = 3.1 | SD = 0.59, CV(%) = 3.0 |
| Precision (Total - Level 26.8 µg/ml) | SD = 0.60, CV(%) = 2.3 | N/A (new device reports only two levels) |
| Method Comparison (Correlation) | $Y=1.00x -0.19$, r = 0.998, Sy.x = 0.39 | $y = 1.00x - 0.8$, r = 0.995 |
| Method Comparison (Range/N) | Range 0.7 - 35.1 µg/ml, N = 114 | Range 1.3 - 38.3 µg/ml, N = 70 |
| Limitations (Bilirubin) | No significant interference up to I index of 60 (approx. 60 mg/dl). | No interference found up to 58 mg/dl (1000 µmol/l). |
| Limitations (Hemoglobin) | No significant interference up to H index of 1000 (approx. 1000 mg/dl). | No interference found up to 1000 mg/dl (10 g/l). |
| Limitations (Lipemia) | No significant interference up to L index of 1000 (approx. 2000 mg/dl Intralipid®). | No interference found up to 1000 mg/dl (10 g/l) of Intralipid®. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Method Comparison (Test Set): 70 samples (N = 70) were used for the new device's method comparison study.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the submitter's country (Finland), it's possible the data originated there, but this is not confirmed.
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 a quantitative diagnostic test (immunoassay), not an imaging device requiring expert interpretation. The "ground truth" for such a device is typically established by comparing its results to a well-established reference method (often the predicate device itself, or a gold standard method like mass spectrometry, though not explicitly stated as distinct from the predicate here). Therefore, the concept of "experts" establishing ground truth in the way it applies to image interpretation in radiology is not directly applicable. The predicate device's measurements serve as the comparator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods (like 2+1 or 3+1) are relevant for studies where human expert disagreement on interpretation is resolved. This is not applicable to a quantitative immunoassay where the comparison is numerical against a reference method. Therefore, the adjudication method is none.
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, an MRMC comparative effectiveness study was not done. This type of study (MRMC, human-in-the-loop, AI assistance) is typically performed for image-based diagnostic aids or systems that augment human decision-making. The device described, a Phenytoin assay, is a standalone quantitative chemical analyzer component (reagent system) and does not involve human "readers" in the diagnostic interpretation cycle in the same way an imaging AI would.
-
Therefore, there is no effect size for human reader improvement with/without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done. The performance metrics (Measuring Range, Precision, Method Comparison, Limitations) presented are characteristics of the device itself (the Phenytoin assay on the T60 analyzer) operating independently to produce a quantitative result. There is no human intervention in the result generation or interpretation to be removed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the new device's performance was established by comparison to a legally marketed predicate device (CEDIA® Phenytoin II assay). For the method comparison study, the predicate device's results were used as the reference against which the new device's results were correlated. For other performance characteristics like precision, internal validation methods would have been used.
8. The sample size for the training set
The document describes a diagnostic assay, not a machine learning or AI algorithm in the conventional sense that would require a distinct "training set." Therefore, information regarding a "training set sample size" is not applicable to this type of device.
9. How the ground truth for the training set was established
As there is no "training set" in the context of an immunoassay, the concept of establishing ground truth for it is not applicable.
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The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin, an anti-convulsant drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.
The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin, an anti-convulsant drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Phenytoin reagent kits.
Acceptance Criteria and Study for Roche ONLINE Phenytoin Assay
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a comparison to a predicate device (Roche CEDIA Phenytoin II Assay), not a study against pre-defined acceptance criteria for a novel device. The "acceptable results compared to the predicate device" serves as the implicit acceptance criterion. The key performance metrics reported are for precision and method comparison.
| Performance Metric | Acceptance Criteria (Implicit - Comparison to Predicate) | Roche ONLINE Phenytoin Assay Performance | Roche CEDIA Phenytoin II Assay Performance (Predicate) |
|---|---|---|---|
| Method Comparison | To be substantially equivalent to the predicate device when compared against the Abbott TDx Phenytoin Assay. | Y = 0.99X - 0.865 (vs Abbott TDx) | Y = 0.99X - 1.43 (vs Abbott TDx) |
| Correlation Coefficient (R) | To be substantially equivalent to the predicate device. | R = 0.992 (vs Abbott TDx) | R = 0.993 (vs Abbott TDx) |
| Measurement Range | To be substantially equivalent to the predicate device. | 1.68 to 40.0 µg/mL | 1.1 to 40.0 µg/mL |
| Precision (Level 1: Mean) | To be substantially equivalent to the predicate device. | 6.49 µg/mL | 6.3 µg/mL |
| Precision (Level 1: CV% within run) | To be substantially equivalent to the predicate device. | 2.7% | 3.2% |
| Precision (Level 1: CV% total) | To be substantially equivalent to the predicate device. | 6.1% | 5.1% |
| Precision (Level 2: Mean) | To be substantially equivalent to the predicate device. | 13.39 µg/mL | 14.8 µg/mL |
| Precision (Level 2: CV% within run) | To be substantially equivalent to the predicate device. | 1.4% | 2.0% |
| Precision (Level 2: CV% total) | To be substantially equivalent to the predicate device. | 4.5% | 3.1% |
| Precision (Level 3: Mean) | To be substantially equivalent to the predicate device. | 22.87 µg/mL | 26.8 µg/mL |
| Precision (Level 3: CV% within run) | To be substantially equivalent to the predicate device. | 1.5% | 1.3% |
| Precision (Level 3: CV% total) | To be substantially equivalent to the predicate device. | 4.3% | 2.3% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Method Comparison):
- Roche ONLINE Phenytoin vs. Abbott TDx Phenytoin Assay: N = 106
- Roche CEDIA Phenytoin II vs. Abbott TDx Phenytoin Assay: N = 108
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective, though clinical diagnostic assay comparisons are typically prospective clinical performance evaluations or studies on patient samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is a clinical chemistry assay for quantitative determination of phenytoin. Ground truth for such assays is typically established by comparing the device's results to a recognized, accurate reference method or a legally marketed predicate device. In this case, the Abbott TDx Phenytoin Assay served as the reference method against which both the new device and the predicate device were compared. No "experts" in the sense of physicians reviewing images or cases are usually involved in establishing ground truth for quantitative laboratory assays; the ground truth is the result from the reference method.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative laboratory assay comparison, not a diagnostic imaging or qualitative assessment requiring adjudication of results from multiple observers. The comparison is against a reference assay.
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 a clinical chemistry assay for quantitative determination of a drug in human samples, not an AI-assisted diagnostic imaging device or a device involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study describes the standalone performance of the Roche ONLINE Phenytoin assay. It quantifies the level of phenytoin directly from human serum or plasma samples on automated clinical chemistry analyzers. There is no human-in-the-loop performance described for the assay itself; the human involvement is in interpreting the quantitative results for clinical decision-making.
7. The type of Ground Truth Used
The ground truth used for the method comparison study was the results obtained from the Abbott TDx Phenytoin Assay, which is a recognized method for phenytoin quantification.
8. The Sample Size for the Training Set
Not applicable. This document describes a traditional in-vitro diagnostic device (IVD) based on reagent systems, not an AI/Machine Learning algorithm that requires a training set. The "training" for such devices involves optimizing the chemical reactions and analytical parameters during development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is not an AI/Machine Learning device that utilizes a training set with established ground truth in the typical computational sense. The performance characteristics of the assay are established through analytical verification and validation studies.
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The Abbott Aeroset® Phenytoin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenytoin in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenytoin concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anti-convulsant medication for the following reasons:
- Serum phenytoin concentrations correlate better with pharmacologic activity than does . dosage because of individual differences in absorption, metabolism, disease states, concomitant medication, and compliance. Serum concentration monitoring helps physicans individualize dosage regimens.
- The hepatic enzyme system for metabolizing phenytoin can become saturated within the . drug's therapeutic range. When this occurs, small dosage alterations can lead to unexpected drug accumulation and clinical toxicity.
- Phenytoin is safe and effective only in a narrow range of serum concentrations. .
- Methods historically used to monitor serum phenytoin concentrations include . chromatographic assays and immunoassays.
The Abbott Aeroset® Phenytoin Assay is a homogenous enzyme assay intended for use in quantitative analysis of Phenytoin in human serum or plasma.
The Abbott Aeroset Phenytoin Assay device is a homogeneous enzyme immunoassay intended for the quantitative analysis of phenytoin in human serum or plasma.
Here's an analysis of the provided information:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparative Analysis: Equivalent to predicate device (Emit® 2000 Phenytoin Assay) with strong correlation. | Comparative Analysis: Correlation of 1.0 with a slope value of 1.04 to the predicate method. |
| Precision (Within-run %CV): Acceptable | Precision (Within-run %CV): Ranging from 1.67% to 1.83% |
| Precision (Total %CV): Acceptable | Precision (Total %CV): Ranging from 2.82% to 3.54% |
2. Sample Size 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/prospective). It only mentions "A Precision study was performed" and "The comparative analysis to the predicate method".
3. Number of Experts and Qualifications
This information is not provided in the document. The nature of this in vitro diagnostic device (quantitative analysis of a chemical compound) typically relies on laboratory measurements and comparison to a predicate device rather than expert interpretation of images or clinical cases.
4. Adjudication Method
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of data (e.g., medical images) to establish ground truth from multiple experts. For this device, the performance is based on analytical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This type of study assesses how AI assistance impacts human reader performance, which is not relevant for a standalone analytical assay like the Abbott Aeroset Phenytoin Assay.
6. Standalone Performance
Yes, a standalone performance was done. The document describes the "Comparative Analysis" and "Precision" studies of the Abbott Aeroset Phenytoin Assay, which represent its performance without human-in-the-loop assistance for the core measurement. The device's output is a quantitative value.
7. Type of Ground Truth Used
The ground truth for the "Comparative Analysis" was the results obtained from the predicate device, Emit® 2000 Phenytoin Assay (K913429). For the "Precision" study, typical ground truth would be based on expected values for control samples or replicate measurements.
8. Sample Size for the Training Set
This information is not provided. For an enzyme immunoassay, the "training set" would typically refer to the data used for assay development, optimization, and calibration curve generation. The document does not detail this.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. For an immunoassay, the training set's ground truth would likely be established through:
- Reference materials: Known concentrations of phenytoin used to create calibration curves.
- Analytical methods: Independent, highly accurate analytical methods (e.g., GC-MS or HPLC) to confirm the concentrations of standards and controls.
- Predicate device results: If the assay was benchmarked against an existing method during development, results from the predicate device would also serve as a form of ground truth for method development.
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ACE® Phenytoin Reagent is intended for use in the quantitative determination of phenytoin in human serum.
ACE® Phenytoin Reagent is intended for the quantitative determination of phenytoin in serum using the ACE® clinical chemistry analyzer.
Phenytoin is one of the most widely prescribed anti-convulsant drugs for the treatment of epilepsy, particulary grand mal epilepsy (major motor), corticol focal seizures and temporal lobe epilepsy.
The ACE® Phenytoin Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to phenytoin and is based on the competition of an enzyme glucose-o-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
The provided document describes the ACE® Phenytoin Reagent, an enzyme immunoassay for the quantitative determination of phenytoin in human serum, and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The submission relies on demonstrating substantial equivalence to a predicate device (Diagnostic Reagents, Inc. (DRI) - Phenytoin Reagent [510(k) Number K945725]). The performance parameters below are compared between the proposed device and the predicate device, implying that the predicate's performance serves as the de-facto acceptance criteria for the proposed device to be considered substantially equivalent.
| Parameter | Predicate Device Performance | Proposed Device Performance | Acceptance Criteria (Implied) |
|---|---|---|---|
| Assay Range | 0.3 µg/mL to 40 µg/mL | 0.6 µg/mL to 40 µg/mL | Comparable to predicate |
| Precision | |||
| Within Run |
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Immunoassay for the in vitro quantitative determination of phenytoin in human serum and plasma.
The CEDIA® Phenytoin II Assay is based on the bacterial enzyme Bgalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.
In the assay, phenytoin in the sample competes with analyte conjugated to one inactive fragment of ß-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed.
This document describes the CEDIA® Phenytoin II Assay, a homogeneous enzyme immunoassay for the quantitative determination of phenytoin in human serum and plasma. The K963840 submission compares this new assay to a predicate device, the CEDIA® Phenytoin Assay (K905689), and other commercially available products.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" for each performance characteristic with pre-defined thresholds. Instead, it presents performance data for the CEDIA® Phenytoin II Assay and compares it to the predicate CEDIA® Phenytoin Assay or another commercially available method (Abbott TDx® Phenytoin). The implication is that performance comparable or superior to these predicate devices constitutes acceptable performance for substantial equivalence.
| Feature | Acceptance Criteria (Implied by Predicate Performance) | CEDIA® Phenytoin II Performance |
|---|---|---|
| Precision | Similar or better %CV values compared to CEDIA® Phenytoin Assay at various levels (e.g., within-run and total %CV in the low 2-5% range). | Modified NCCLS (µg/mL): |
- Level (Sample): 6.30 (N=120), Within-Run %CV: 3.2, Total %CV: 5.1
- Level (Control 2): 14.80 (N=120), Within-Run %CV: 2.0, Total %CV: 3.1
- Level (Control 3): 26.75 (N=120), Within-Run %CV: 1.3, Total %CV: 2.3
(Comparison to CEDIA® Phenytoin Assay: Low 10.7 (N=120), Within-Run %CV: 3.6, Total %CV: 4.7; Mid 17.7 (N=120), Within-Run %CV: 2.0, Total %CV: 3.8; High 35.4 (N=119), Within-Run %CV: 1.5, Total %CV: 3.3) |
| Lower Detection Limit | ≤ 0.6 µg/mL (matching TDx Phenytoin) | 0.6 µg/mL |
| Linearity | Range of 0.6 - 40.0 µg/mL (matching TDx Phenytoin) | 0.6 - 40.0 µg/mL |
| Method Comparison | Strong correlation (r > 0.99) and agreement with predicate devices (CEDIA® Phenytoin and Abbott TDx® Phenytoin), with a slope close to 1 and intercept close to 0. | Vs CEDIA® Phenytoin (N=114): - Least Squares: y = 1.00x - 0.17, r = 0.998, SEE = 0.55
- Deming's: y = 1.00x - 0.19, r = 0.998, SEE = 0.39
Vs Abbott TDx® Phenytoin (N=92):
- Least Squares: y = 0.984x - 0.10, r = 0.994, SEE = null |
| Interfering Substances | No significant interference at or above specified concentrations of bilirubin, hemoglobin, lipemia, total protein, and rheumatoid factor. | No interference at: - Bilirubin: 66 mg/dL (Improved from 50 mg/dL for predicate)
- Hemoglobin: 1000 mg/dL (Same as predicate)
- Lipemia: 1000 mg/dL (Same as predicate)
- Total Protein: 12.0 g/dL (Slightly less than 13 g/dL for predicate)
- Rheumatoid Factor: 100 IU/mL (Less than 180 IU/mL for predicate) |
| Specificity (% Cross-reactivity) | Comparable or better (lower) cross-reactivity for structurally similar compounds (HPPH, 5-MPPH) compared to the predicate device. | - HPPH: 1.8% (Slightly higher than 1.4% for predicate) - 5-MPPH: 5.7% (Higher than 4.8% for predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision:
- For the CEDIA® Phenytoin II Assay, N=120 for each of the three levels (Sample, Control 2, Control 3).
- For the predicate CEDIA® Phenytoin Assay, N=120 for Low and Mid levels, and N=119 for the High level.
- Method Comparison:
- Vs CEDIA® Phenytoin: N=114
- Vs Abbott TDx® Phenytoin: N=92
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's a 510(k) submission for a new assay, the data is almost certainly prospective as it's generated specifically for the submission. The origin is implied to be from Boehringer Mannheim Corporation, likely from studies conducted in the USA where the company is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to a quantitative immunoassay device. The "ground truth" for these tests comes from samples with known concentrations (e.g., controls, spiked samples) or from reference methods (the predicate devices in this case). There are no human "experts" establishing a subjective ground truth for the test results.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a quantitative assay, and "adjudication" by experts is not a relevant concept for determining the ground truth for chemical measurements. The comparison is between analytical results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for diagnostic imaging or subjective interpretations where multiple human readers interpret cases. This submission is for a quantitative immunoassay, which does not involve human readers interpreting images or cases, nor does it describe human-in-the-loop performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the entire performance evaluation presented is a standalone (algorithm/device-only) performance. The assay measures phenytoin levels quantitatively. There is no human intervention or interpretation of the assay's direct output (spectrophotometric readings) that would constitute a "human-in-the-loop" component.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation appears to be:
- Known concentrations: For precision studies, control materials with known phenytoin concentrations are used. For linearity, samples with varying known concentrations are typically prepared.
- Reference method results: For method comparison, the results from the CEDIA® Phenytoin Assay (the predicate) and the Abbott TDx® Phenytoin (another established method) serve as the reference or "ground truth" against which the new assay's measurements are compared.
8. The Sample Size for the Training Set
The document does not provide details on a "training set" in the context of machine learning, because this is an immunoassay, not an AI/ML algorithm that requires a training set of data. The development of the assay reagents and parameters would involve optimization and calibration, but this is distinct from a "training set" for an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or indication of an AI/ML-based "training set" for this immunoassay device. The development process would involve establishing accuracy and performance characteristics using various laboratory methods, certified reference materials, and comparative studies.
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