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510(k) Data Aggregation
(133 days)
KLT
In vitro test for the quantitative determination of carbamazepine in serum and plasma on Roche/Hitachi cobas c systems.
Measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
The ONLINE TDM Carbamazepine Gen. 4 assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. It is a homogeneous microparticle agglutination immunoassay based on the kinetic interaction of microparticles in solution (KIMS). Biotinylated drug hapten serves as the binding partner to anticarbamazepine antibody and streptavidin coated latex beads. A competitive reaction to a limited amount of specific anti-carbamazepine antibody takes place between the hapten and free carbamazepine in the sample. A decrease in the apparent signal produced by the microparticle agglutination is proportional to the amount of drug present in the sample.
Here's an analysis of the provided text, focusing on acceptance criteria and the study proving the device meets them:
Device Name: ONLINE TDM Carbamazepine Gen.4
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance |
|---|---|---|
| Detection Limit | Limit of Blank (LoB) | 0.3 µg/mL (Claimed: 0.5 µg/mL) |
| Limit of Detection (LoD) | 0.5 µg/mL (Claimed: 1.0 µg/mL) | |
| Limit of Quantitation (LoQ) | 1.4 µg/mL (Claimed: 2.0 µg/mL) | |
| Precision | Repeatability (CV%) | TDM Control 1: 2.2% |
| TDM Control 2: 1.4% | ||
| TDM Control 3: 1.3% | ||
| Human Serum 1: 2.7% | ||
| Human Serum 2: 2.1% | ||
| Human Serum 3: 1.8% | ||
| Human Serum 4: 1.3% | ||
| Human Serum 5: 1.4% | ||
| Intermediate Precision (CV%) | TDM Control 1: 2.8% | |
| TDM Control 2: 2.3% | ||
| TDM Control 3: 1.8% | ||
| Human Serum 1: 3.3% | ||
| Human Serum 2: 2.9% | ||
| Human Serum 3: 2.6% | ||
| Human Serum 4: 2.4% | ||
| Human Serum 5: 2.9% | ||
| Linearity | Pearson correlation coefficient (R) | Serum: 0.997 |
| K2-EDTA, Plasma: 0.999 | ||
| Measuring Range | Claimed Measuring Range | 2.0 to 20.0 µg/mL |
| Matrix Comparison | Correlation (r) | Serum vs. Serum Gel Separation: 0.989 |
| Serum vs. Li-heparin: 0.991 | ||
| Serum vs. Na-heparin: 0.990 | ||
| Serum vs. K2-EDTA: 0.988 | ||
| Serum vs. K3-EDTA: 0.994 | ||
| Interferences (Endogenous) | Hemolysis (H index) | Up to 1000 (approx. Hgb 1000 mg/dL) |
| Icterus (I index) | Up to 50 (approx. bilirubin 50 mg/dL) | |
| Lipemia (L index) | Up to 2000 (approx. triglyceride 1000 mg/dL) | |
| Cholesterol | Up to 600 mg/dL | |
| Rheumatoid Factor | Up to 1200 IU/mL | |
| Total Protein | Up to 13 g/dL | |
| Interferences (Drugs) | Non-interference at specific concentrations for 16 common drugs | (See Table 7 in document for specific concentrations) |
| Cross-reactivity | % Cross reactivity at 3 µg/mL and 12 µg/mL for various compounds | (See Table 8 in document for specific values for 27 compounds) |
| Method Comparison to Predicate | Deming Regression (r) | 0.993 |
2. Sample Size Used for the Test Set and Data Provenance:
- Detection Limit (LoB): 60 measured values (10-fold determinations per run on one instrument, 6 runs over 3 days).
- Detection Limit (LoD): 36 determinations (5 samples, 2-fold determination per run, 6 runs over 3 days).
- Detection Limit (LoQ): Not explicitly stated, but "Nine samples are prepared... tested in two aliquots over at least three days on one analyzer, 2 runs per day for 3 lots." This implies a significant number of data points.
- Precision: "Two runs per day for ≥ 21 days on the same analyzer." This amounts to at least 42 runs for each sample type. Numerous samples were tested (TDM Controls 1, 2, 3 and Human Serums 1-5).
- Linearity: "Eleven levels (including the high concentration pool and diluent)." Tested for both human serum and plasma.
- Matrix Comparison: "33 full tubes" of paired serum and plasma samples from single donors.
- Interferences (Endogenous): Two human sample pools, varying concentrations of interfering substances.
- Interferences (Drugs): Two human sample pools, spiked with 16 different drugs.
- Cross-reactivity: Two carbamazepine concentrations (3 µg/mL and 12 µg/mL) tested against 27 different compounds.
- Method Comparison to Predicate: "One hundred single native human samples of patients taking carbamazepine."
Data Provenance: The document does not explicitly state the country of origin for the samples. It mentions "human serum," "human serum sample pool," and "single native human samples of patients." It is implied to be a retrospective analysis of samples collected for the purpose of testing, but it's not explicitly stated as retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is an in-vitro diagnostic (IVD) for quantitative determination of a drug concentration. The "ground truth" for these tests is established by reference methods, calibrators, and known concentrations, not by expert interpretation of images or clinical cases. For example, LoQ uses LC/MS as the expected/target value.
4. Adjudication Method for the Test Set:
Not applicable. As this is an IVD for quantitative measurement, there is no subjective interpretation requiring adjudication among experts. The "ground truth" is determined by analytical methods with known accuracy and precision (e.g., LC/MS for LoQ).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC study was not done. This type of study is relevant for imaging devices or tests where human readers interpret results, often with and without AI assistance. This device is an automated quantitative assay, so human reader involvement in the primary measurement is not a factor.
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 assessment. The device quantifies carbamazepine levels directly from samples. The results are compared against established analytical standards and a predicate device.
7. The Type of Ground Truth Used:
The ground truth for the performance studies is established by:
- Reference Methods: For LoQ, LC/MS (Liquid Chromatography/Mass Spectrometry) is explicitly stated as the method for determining the expected or target value.
- Known Concentrations: Samples with known concentrations of carbamazepine are used for various tests like detection limits, precision, linearity, and interference studies.
- Predicate Device Comparison: The reference standard for the "Method Comparison to Predicate" is the results obtained from the predicate device (ONLINE TDM Carbamazepine, K031902) on the cobas c 501.
- USP Reference Standards: The traceability for the assay calibration is stated as being standardized against USP reference standards.
8. The Sample Size for the Training Set:
Not applicable. This device is an immunoassay (KIMS technology), not a machine learning or AI-based algorithm that requires a "training set" in the conventional sense. The "training" of such a system would involve optimizing assay reagents and parameters during development, not a data-driven training dataset for an AI model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reasons as point 8. The device's "training" is in its chemical and biological design, optimization, and manufacturing, rather than data-driven ground truth establishment for a training set.
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(203 days)
KLT
The Abbott Carbamazepine assay is used for the in vitro quantitative measurement of carbamazepine in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
The Carbamazepine Assay kit is supplied ready-to-use in liquid form, for storage at 2 to 8°C. Each Carbamazepine Assay kit is packaged in a rectangular cardboard box divided into three sections. One section will contain three bottles of Antibody Reagent (R1), one section will contain three bottles of Microparticle Reagent (R2), and the last section will contain the package insert. Each kit is sufficient for 300 tests.
Here is a summary of the acceptance criteria and the study details for the Abbott Carbamazepine Assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Sensitivity (LOQ) | Lowest concentration with inter-assay precision CV at ≤ 7% | 1.9 µg/mL (Meets design acceptance criteria) |
| Precision | Total run %CV ≤ 6.3% | Total run %CV ≤ 6.3% (Meets design acceptance criteria) |
| Spike Recovery | Recovery within ±10% or ±0.4 µg/mL error of HPLC results | All samples recovered within ±10% or ±0.4 µg/mL error of the HPLC results. |
| Method Comparison (vs. HPLC) | Good correlation expected | Relationship: y = 1.093x + 0.372, R = 0.9584 (n=105) - "correlated well" |
| Method Comparison (vs. Predicate) | Good correlation with Abbott Aeroset Carbamazepine Assay (K993028) expected | Relationship: y = 0.905x + 0.564, R = 0.9675 (n=103) - "correlated well" |
| Matrix Comparison | Confirmation of suitability for various matrices | Suitable for use in: serum (glass/plastic), SST (plastic), plasma with sodium fluoride/potassium oxalate (plastic), plasma with sodium heparin (plastic/glass), plasma with lithium heparin (plastic with/without gel), plasma with K3 EDTA (glass/plastic), plasma with K2 EDTA (plastic), and sodium citrate (plastic/glass). |
| Specificity | Minimal to no cross-reactivity to other medications; minimal to no interference from endogenous substances | Showed minimal to no cross-reactivity to other medications. Showed minimal to no interference to endogenous substances up to tested concentrations. |
| Linearity | Linear performance throughout the assay range | Performs in a linear fashion from 0.5 to 20 µg/mL. |
| Onboard Stability | Stable for a specified period on the ARCHITECT cSystem | Reagents stable onboard for up to 45 days. |
| Standard Curve Calibration Stability | Stable for a specified period on the ARCHITECT cSystem | Standard curve calibration stable for up to 7 days. |
| Reagent Shelf Life Stability | Stable for a specified period at 2-8°C | Reagents stable at 2-8°C for 24 months. |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Method Comparison (vs. HPLC): 105 samples
- Sample Size for Method Comparison (vs. Predicate): 103 samples
- Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin of the data. The context of a 510(k) submission for an in vitro diagnostic usually implies controlled laboratory studies.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- This device is an in vitro diagnostic assay, where "ground truth" is typically established by reference methods or instruments rather than expert human interpretation of images/cases.
- For the method comparison studies, the "ground truth" was established by comparing the device's results to:
- HPLC (High-Performance Liquid Chromatography): This is a gold standard analytical chemistry technique for quantifying carbamazepine. The document does not specify human experts or their qualifications for interpreting HPLC results; the HPLC itself serves as the reference.
- Abbott Aeroset® Carbamazepine Assay (K993028): This is the legally marketed predicate device, used as a comparative reference.
4. Adjudication Method for the Test Set
- Not applicable. As described above, "ground truth" for this type of device is established by instrumental reference methods (HPLC) or comparison to a predicate device, rather than human adjudication of cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI algorithms that assist human readers in making diagnostic interpretations. The Abbott Carbamazepine Assay is an in vitro diagnostic for quantitative measurement of a drug in bodily fluids and does not involve human readers interpreting "cases" in the same way.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance assessment was conducted. The "device performance" metrics listed in the summary (Functional Sensitivity, Precision, Spike Recovery, Method Comparison, Linearity, Stability, etc.) directly reflect the performance of the assay system (reagents plus ARCHITECT cSystems instrument) without human-in-the-loop interpretation. The device's output is a quantitative measurement, not an interpretation requiring human assistance.
7. Type of Ground Truth Used
- The ground truth primarily used for evaluating the device's performance was:
- Reference method data (HPLC): For accuracy and recovery studies.
- Predicate device data (Abbott Aeroset® Carbamazepine Assay): For method comparison to demonstrate substantial equivalence.
- Internal analytical standards and controls: For precision, linearity, and stability studies.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" sample size. For an in vitro diagnostic assay, development typically involves extensive characterization and optimization of reagents and assay parameters rather than training a machine learning algorithm with a distinct dataset. The "development" or "optimization" samples are integral to method formulation, but aren't typically referred to as a "training set" in the context of device submission for this type of product.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not explicitly described as a "training set" with established ground truth in the traditional sense. For IVD assays, the process involves calibrating the assay using known concentrations of the analyte (carbamazepine calibrators) that serve as a reference for quantifying unknown samples. These calibrators and controls have precisely defined concentrations, which act as the "ground truth" for establishing the assay's curve and performance characteristics during development and ongoing use. The development process itself ensures the assay yields accurate results against these known standards.
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(305 days)
KLT
The ARCHITECT iCarbamazepine assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma (collected in lithium heparin, sodium heparin, dipotassium EDTA or sodium EDTA tubes) on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
The ARCHITECT iCarbamazepine Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma.
The ARCHITECT iCarbamazepine assay is a one-step immunoassay for the quantitative measurement of carbamazepine in human serum or plasma using CMIA technology with flexible assay protocols referred to as Chemiflex.
In the ARCHITECT iCarbamazepine assay, sample, anti-carbamazepine coated paramagnetic microparticles, and carbamazepine acridinium-labeled conjugate are combined to create a reaction mixture. The anti-carbamazepine coated microparticles bind to carbamazepine present in the sample and the carbamazepine 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 carbamazepine in the sample and the RLUs detected by the ARCHITECT i System optics.
The provided 510(k) summary (K103627) describes the ARCHITECT iCarbamazepine assay, an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of carbamazepine in human serum or plasma.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines analytical performance studies but does not explicitly state specific numerical acceptance criteria for each study (e.g., a required correlation coefficient for linearity or specific CV% for precision). Instead, it lists the types of studies performed to demonstrate substantial equivalence to the predicate device, the AxSYM Carbamazepine assay. The overall conclusion is that the ARCHITECT iCarbamazepine assay "is substantially equivalent to the AxSYM Carbamazepine assay in terms of analytical performance data."
| Acceptance Criteria (Stated as study types performed to show equivalence) | Reported Device Performance (Implied as meeting criteria for substantial equivalence) |
|---|---|
| Precision | Studies demonstrated substantial equivalence to predicate. |
| Sensitivity (Limit of Blank, Limit of Detection, and Limit of Quantitation) | Studies demonstrated substantial equivalence to predicate. |
| Linearity | Studies demonstrated substantial equivalence to predicate. |
| Interferences | Studies demonstrated substantial equivalence to predicate. |
| Recovery | Studies demonstrated substantial equivalence to predicate. |
| Manual Dilution | Studies demonstrated substantial equivalence to predicate. |
| Matrix Comparison (Tube Type) | Studies demonstrated substantial equivalence to predicate. |
| Method Comparison (Correlation) | Studies demonstrated substantial equivalence to predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for the test sets in any of the analytical performance studies.
The document also does not mention the country of origin of the data or whether the studies were retrospective or prospective. These are typically detailed in the full 510(k) submission but are not present in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not refer to "experts" or "ground truth" in the context of clinical interpretation or decision-making, as this is a quantitative immunoassay device. The "ground truth" for this type of device would be established by reference methods or comparison to a legally marketed predicate device, as seen in the "Method Comparison (Correlation)" study. Therefore, the concept of qualified experts establishing ground truth in the way it might apply to image-based diagnostic AI is not relevant here.
4. Adjudication Method for the Test Set:
Not applicable, as the device performs quantitative measurements and does not involve human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices that assist human readers (e.g., radiologists for medical images). The ARCHITECT iCarbamazepine assay is a standalone quantitative measurement device, not an AI assistant for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are inherently standalone performance evaluations of the ARCHITECT iCarbamazepine assay. The device provides a quantitative measurement of carbamazepine levels directly, without human interpretation of the assay results in the way one would interpret an image. The "Method Comparison (Correlation)" study, for instance, directly compares the device's quantitative output to that of the predicate device.
7. The Type of Ground Truth Used:
For a quantitative diagnostic device like this, the "ground truth" for performance evaluation is typically established through:
- Reference methods: Highly accurate and precise methods known to provide true values.
- Comparison to a legally marketed predicate device: This is explicitly stated in the document ("Method Comparison (Correlation)") where the ARCHITECT iCarbamazepine assay's results are compared to those of the AxSYM Carbamazepine assay (K935374).
- Known concentrations: For studies like linearity, sensitivity, and recovery, samples with precisely known concentrations of the analyte are used.
8. The Sample Size for the Training Set:
The document does not mention a "training set" as this device does not appear to employ machine learning or artificial intelligence in a way that requires a distinct training phase. It is a traditional immunoassay, and its performance is determined by its chemical and mechanical design, not by learning from a dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set for this traditional immunoassay device.
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(357 days)
KLT
The Carbamazepine is intended for the quantitative in vitro diagnostic determination of the carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy.
The Valproic Acid is intended for the quantitative in vitro diagnostic determination of the valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid 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 981645 Carbamazepine and kit code 981650 Valproic acid assays on T60 Analyzer.
Not Found
The provided text describes the 510(k) submission for Thermo Fisher Scientific Oy's Carbamazepine and Valproic Acid test systems and TDM Calibration set B. The document outlines the intended use, indications for use, and a comparison with predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily in comparison to a predicate device, focusing on similar performance characteristics. The document presents performance data for "New device #1" (Thermo Fisher Scientific Oy's device) and "Predicate device #1" (Microgenics Corporation CEDIA® Carbamazepine II/Valproic Acid II).
Carbamazepine Assay:
| Attribute | Acceptance Criteria (Predicate Device #1) | Reported Device Performance (New Device #1) |
|---|---|---|
| Intended Use | For quantitation of carbamazepine in human serum or plasma using automated clinical chemistry analyzers, for diagnosis and treatment of overdose and monitoring levels to ensure proper therapy. | For quantitative determination of carbamazepine concentration in human serum on T60 analyzer, for diagnosis and treatment of overdose and monitoring levels to help ensure proper therapy. |
| Indications for Use | Same as Intended Use. | For quantitative in vitro diagnostic determination of carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers, for diagnosis and treatment of overdose and monitoring levels to help ensure proper therapy. |
| Assay Protocol | Recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. | Recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. |
| Traceability/Standardization | Calibration values traceable to USP reference materials prepared gravimetrically to drug-free human serum. | 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). | Human Serum. |
| Reagent Storage | Store at 2-8 °C. Do not freeze. Stability of unopened components indicated on labels. | Unopened reagents stable at 2-8 °C until expiration date. DO NOT FREEZE. |
| Expected Values (Therapeutic Range for adults) | Ranges such as 5-12 µg/ml, 8-12 µg/ml, 3-12 µg/ml, 6-10 µg/ml, 4-10 µg/ml, 4-8 µg/ml, 4-12 µg/ml. | Suggested ranges: 4 - 12 µg/ml or 17 - 51 µmol/l (1); 4 - 10 µg/ml or 17 - 42 µmol/l (2). |
| Measuring Range | Between 0.5 µg/ml and approximately 20 µg/ml. | From 1.0 µg/ml to 19.0 µg/ml. |
| Precision | Within run: Level 4.2 µg/ml (SD=0.06, CV=1.5%), Level 10.6 µg/ml (SD=0.08, CV=0.8%), Level 16.8 µg/ml (SD=0.12, CV=0.7%). Total: Level 4.2 µg/ml (SD=0.15, CV=3.5%), Level 10.6 µg/ml (SD=0.21, CV=2.0%), Level 16.8 µg/ml (SD=0.29, CV=1.7%). | Within run: Level 3.0 µg/ml (SD=0.09, CV=2.8%), Level 9.5 µg/ml (SD=0.14, CV=1.5%), Level 15.0 µg/ml (SD=0.16, CV=1.1%). Between run: Level 3.0 µg/ml (SD=0.07, CV=2.4%), Level 15.0 µg/ml (SD=0.14, CV=0.9%). Total: Level 3.0 µg/ml (SD=0.19, CV=6.3%), Level 9.5 µg/ml (SD=0.32, CV=3.3%), Level 15.0 µg/ml (SD=0.42, CV=2.8%). |
| Method Comparison (Deming Regression) | Y = 1.04x - 0.04; r = 0.999; Sy.x = 0.26; Range 1.3 - 19.8 µg/ml; N = 103 (vs. previous CEDIA Carbamazepine assay). | y = 0.98 x + 0.02; r = 0.993; Range 1.9 - 19.6 µg/ml; N = 134. |
| Limitations (Interference) | Hemoglobin up to 1000 mg/dl, Bilirubin up to 66 mg/dl, Triglyceride up to 1000 mg/dl, Total protein up to 12 g/dl, Rheumatoid factor up to 180 IU/ml. | No interference found: Hemoglobin up to 1000 mg/dl, Bilirubin up to 58 mg/dl, Lipemia up to 1000 mg/dl of Intralipid®. |
Valproic Acid Assay:
| Attribute | Acceptance Criteria (Predicate Device #1) | Reported Device Performance (New Device #1) |
|---|---|---|
| Intended Use | For quantitation of valproic acid in human serum or plasma using automated clinical chemistry analyzers, for diagnosis and treatment of overdose and monitoring levels to ensure proper therapy. | For quantitative determination of valproic acid concentration in human serum on T60 instrument, for diagnosis and treatment of overdose and monitoring levels to help ensure proper therapy. |
| Indications for Use | Same as Intended Use. | For quantitative in vitro diagnostic determination of valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers, for diagnosis and treatment of overdose and monitoring levels to help ensure proper therapy. |
| Assay Protocol | Recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. | Recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. |
| Traceability/Standardization | Calibration values traceable to USP reference materials prepared gravimetrically to drug-free human serum. | 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). | Human Serum. |
| Reagent Storage | Store at 2-8 °C. Do not freeze. Stability of unopened components indicated on labels. | Unopened reagents stable at 2-8 °C until expiration date. DO NOT FREEZE. |
| Expected Values (Therapeutic range for adults) | Ranges such as 50-100 µg/ml, 40-90 µg/ml. Toxic >100 µg/ml. | 50 - 100 µg/ml or 347 - 693 µmol/l (1,2). |
| Measuring Range | Between 3.0 µg/ml and approximately 150 µg/ml. | From 3.0 µg/ml to 142.5 µg/ml. |
| Precision | Within run: Level 24.4 µg/ml (SD=0.59, CV=2.4%), Level 95.0 µg/ml (SD=1.43, CV=1.5%), Level 136.8 µg/ml (SD=1.81, CV=1.3%). Total: Level 24.4 µg/ml (SD=0.83, CV=3.4%), Level 95.0 µg/ml (SD=1.93, CV=2.0%), Level 136.8 µg/ml (SD=2.48, CV=1.8%). | Within run: Level 35.0 µg/ml (SD=0.43, CV=1.2%), Level 81.1 µg/ml (SD=0.81, CV=1.0%), Level 113.6 µg/ml (SD=1.01, CV=0.9%). Between run: Level 35.0 µg/ml (SD=0.61, CV=1.8%), Level 81.1 µg/ml (SD=1.08, CV=1.3%), Level 113.6 µg/ml (SD=1.07, CV=0.9%). Total: Level 35.0 µg/ml (SD=1.90, CV=5.4%), Level 81.1 µg/ml (SD=3.15, CV=3.9%), Level 113.6 µg/ml (SD=3.11, CV=2.7%). |
| Method Comparison (Deming Regression) | Y = 1.08x - 0.61; r = 0.972; Sy.x = 7.042; Range 2.6 - 119.8 µg/ml; N = 77 (vs. commercially available fluorescence polarization immunoassay). | y = 0.996 x + 1.4; r = 0.993; Range 3.2 - 143.4 µg/ml; N = 136. |
| Limitations (Interference) | Hemoglobin up to 1000 mg/dl, Bilirubin up to 60 mg/dl, Triglyceride up to 1000 mg/dl, Total protein up to 10 g/dl, IgA up to 790 mg/dl, IgG up to 4300 mg/dl, IgM up to 840 mg/dl, Rheumatoid factor up to 200 IU/ml. | No interference found: Hemoglobin up to 1000 mg/dl, Bilirubin up to 58 mg/dl, Lipemia up to 1000 mg/dl of Intralipid®. |
2. Sample sizes used for the test set and the data provenance
- Carbamazepine:
- Method Comparison (test set): N = 134 samples (Carbamazepine).
- Provenance: Not explicitly stated, but clinical chemistry assays typically use de-identified human serum samples. The document doesn't specify if the data is retrospective or prospective, or the country of origin.
- Valproic Acid:
- Method Comparison (test set): N = 136 samples (Valproic Acid).
- Provenance: Not explicitly stated, but clinical chemistry assays typically use de-identified human serum samples. The document doesn't specify if the data is retrospective or prospective, or the country of origin.
- Precision (Carbamazepine & Valproic Acid): Tested at multiple levels (3 for each assay). The number of replicates or runs to achieve the reported SD and CV values is not explicitly stated in this summary but is typically part of the full validation report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For these types of quantitative in vitro diagnostic devices, "ground truth" is typically established by comparing the device's measurements against a recognized reference method or a predicate device that has established accuracy, rather than expert consensus on a clinical diagnosis. The predicate device's performance data is used as the comparative "truth" for demonstrating substantial equivalence.
4. Adjudication method for the test set
This is not applicable/provided as the study focuses on quantitative measurement comparison rather than diagnostic interpretation requiring adjudication. The method comparison studies for both Carbamazepine and Valproic Acid used Deming regression to compare the new device's measurements against the predicate device's measurements.
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
This is not applicable. This document describes an in vitro diagnostic device (a laboratory test for drug levels) and not an imaging or interpretive AI-driven diagnostic system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a standalone in vitro diagnostic system (reagents and an analyzer) which performs quantitative measurements of drug concentrations. The results are then used by healthcare professionals for diagnosis and treatment. In this context, the "standalone" performance refers to the analytical performance of the device itself (precision, measuring range, method comparison) as detailed in the tables. There isn't an "algorithm only" component in the sense of a software-AI device, but rather a chemical assay coupled with an automated analyzer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the method comparison studies was the measurements obtained from the predicate devices (CEDIA® Carbamazepine II and a commercially available fluorescence polarization immunoassay for Valproic Acid). For precision studies, "truth" is established by the known concentrations of quality control materials. The overall goal is to demonstrate that the new device's measurements correlate closely with these established methods.
8. The sample size for the training set
This information is not provided in the summary. For in vitro diagnostic assays, "training set" is usually not explicitly defined in the same way as for AI/ML models. Assay development and optimization involve extensive testing with various samples, but this isn't typically presented as a distinct "training set" in 510(k) summaries for traditional IVDs.
9. How the ground truth for the training set was established
This information is not provided for the reasons mentioned in point 8.
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The Bayer ADVIA IMS Carbamazepine method is for in vitro diagnostic use to measure the antiepileptic drug carbamazepine in human serum and plasma. Measurements of carbamazepine are used as an aid in the diagnosis and treatment of carbamazepine overdose, and used as an aid in monitoring therapeutic levels of carbamazepine to ensure appropriate therapy.
The Bayer ADVIA IMS Carbamazepine calibrator is for in vitro diagnostic use in the calibration of carbamazepine using the ADVIA® IMS system.
This in vitro method is intended to quantitatively measure the antiepileptic drug carbamazepine in human serum and plasma on the Bayer ADVIA® IMS systems.
1. Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (ADVIA IMS) | Predicate Device Performance (Bayer Centaur) |
|---|---|---|---|
| Minimum Detectable Concentration (MDC) | Lower is better | 0.20 µg/mL | 0.25 µg/mL |
| Imprecision: Level 2.62 µg/mL (Total CV%) | Lower is better | 4.6% | 9.2% (at 3.28 µg/mL) |
| Imprecision: Level 5.63 µg/mL (Total CV%) | Lower is better | 2.6% | 8.2% (at 5.79 µg/mL) |
| Imprecision: Level 9.19 µg/mL (Total CV%) | Lower is better | 2.5% | 8.4% (at 9.85 µg/mL) |
| Correlation (R) | Close to 1.0 | 0.988 | - |
| Regression Equation | Close to Y=1.00X + 0.00 | Y=1.00X + 0.01 | - |
| Syx (Standard Error of the Estimate) | Lower is better | 0.80 µg/mL | - |
| Analytical Range | Wider is better | 0.20 µg/mL to 22.14 µg/mL | - |
| Interfering Substances: Bilirubin (unconjugated) % change | Minimal (e.g., |
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The ONLINE TDM Carbamazepine assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. This neuroleptic drug assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of carbamazepine.
The ONLINE TDM Carbamazepine assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. In combination with other clinical information, monitoring carbamazepine levels provides physicians with an effective tool to aid in adjusting dosage and achieving optimal therapeutic effect while avoiding both sub-therapeutic and toxic drug levels. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Carbamazepine reagent kits.
The ONLINE TDM Carbamazepine assay is a homogeneous microparticle agglutination immunoassay. It is a two-reagent system used for the detection of carbamazepine in serum. Kinetic interaction of microparticles (KIMS) will be measured using Roche Diagnostics / Hitachi families of automated analyzers. In this technology biotinylated drug hapten serves as the binding partner to 1.) anti-carbamazepine antibody and 2.) streptavidin coated latex A competitive reaction to a limited amount of specific antibeads. carbamazepine antibody takes place between the hapten and free carbamazepine in the serum sample. A decrease in the apparent signal is proportional to the amount of drug present in the sample.
Here's an analysis of the acceptance criteria and study details for the Roche ONLINE TDM Carbamazepine assay, based on the provided 510(k) summary:
The device being assessed is the Roche ONLINE TDM Carbamazepine assay.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Roche ONLINE TDM Carbamazepine assay are primarily inferred through comparison to its predicate device, the Roche COBAS INTEGRA Carbamazepine assay (K951595). The study aims to demonstrate substantial equivalence across key performance characteristics. The document doesn't explicitly state numerical "acceptance criteria" but rather presents the performance of both the new device and the predicate for direct comparison.
| Performance Characteristic | Acceptance Criteria (Inferred from Predicate Performance or General Standards for Substantial Equivalence) | Roche ONLINE TDM Carbamazepine Performance (New Device) |
|---|---|---|
| Precision (Within run) | Comparable to predicate: | Control 1 (2.8 µg/ml): SD 0.05, CV% 1.7 |
| - SD (µg/ml) | - Control 1: 0.08 | Control 2 (8.3 µg/ml): SD 0.13, CV% 1.5 |
| - CV% | - Control 2: 0.17 | Control 3 (14.1 µg/ml): SD 0.21, CV% 1.5 |
| - Control 3: 0.31 | ||
| Precision (Total) | Comparable to predicate: | Control 1 (2.8 µg/ml): SD 0.15, CV% 5.6 |
| - SD (µg/ml) | - Control 1: 0.12 | Control 2 (8.3 µg/ml): SD 0.36, CV% 4.3 |
| - CV% | - Control 2: 0.24 | Control 3 (14.1 µg/ml): SD 0.55, CV% 3.9 |
| - Control 3: 0.52 | ||
| Method Comparison | High correlation to predicate and linearity over relevant range (e.g., r > 0.95) | y=1.062x - 0.16, r=0.985 (N=103, Range = 0.5-11.93 µg/ml) |
| - Correlation (r) | ||
| - Regression Equation | ||
| Other (General) | Acceptable results provided for: Lower detection limit, specificity, interfering substances | "All of the evaluation studies gave acceptable results compared to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Method Comparison (Test Set):
- N = 103 for the comparison between the ONLINE TDM Carbamazepine and the COBAS INTEGRA Carbamazepine (FPIA) method.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for an in-vitro diagnostic, it is highly likely these were prospective clinical laboratory evaluations conducted as part of the validation process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the summary. For an in-vitro diagnostic device like this, the "ground truth" would typically refer to the reference method or comparative method results, which are obtained directly from laboratory measurements rather than expert consensus on images or clinical assessments.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology reads). This is an in-vitro diagnostic device (immunoassay) for quantitative determination of a drug level. Therefore, no adjudication method (in the sense of human expert disagreement resolution) was used or is relevant for this type of device performance evaluation. The "ground truth" is established through other laboratory methods.
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 medical imaging devices where multiple human readers interpret cases. This device is an automated immunoassay, not an imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary evaluation presented is a standalone (algorithm only) performance study. The device is an automated clinical chemistry analyzer for quantitative determination of carbamazepine. Its performance (precision, method comparison) is assessed as a direct output of the instrument without human interpretation playing a role in the measurement itself, beyond standard laboratory procedures and quality control.
7. The Type of Ground Truth Used
The "ground truth" for the test set (method comparison) was established by using the predicate device's measurement (Roche COBAS INTEGRA Carbamazepine assay, specifically its FPIA method) as the comparative standard. The new device's results are then correlated against these predicate results. This is a common approach for demonstrating substantial equivalence for IVDs.
8. The Sample Size for the Training Set
The document does not provide information on a training set size. For an immunoassay, particularly one demonstrating substantial equivalence to a predicate, the development process might involve internal optimization and validation, but the 510(k) summary focuses on the final performance evaluation data presented to demonstrate equivalence. It's not a machine learning model that would typically have a distinct 'training set' in the way an AI algorithm does.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" (in the context of AI/ML) is mentioned, the method for establishing its ground truth is not applicable/not provided in this summary. Any internal development or optimization would rely on established laboratory reference methods for carbamazepine quantification.
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The Randox Laboratories Ltd. Carbamazepine Test Kit is an in vitro diagnostic reagent for the quantitative determination of carbamazepine in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with carbamazepine which, in the presence of carbamazepine antibody solution, rapidly agglutinate. When a sample containing carbamazepine is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of carbamazepine in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of carbamazepine in the sample.
Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine use or overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.
These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Ltd. Carbamazepine Test Kit is an in vitro diagnostic reagent for the quantitative determination of carbamazepine in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with carbamazepine which, in the presence of carbamazepine antibody solution, rapidly agglutinate. When a sample containing carbamazepine is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of carbamazepine in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of carbamazepine in the sample.
The provided document is a 510(k) clearance letter from the FDA for a Carbamazepine test kit. It is a regulatory document and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and performs as safely and effectively. However, it does not detail the specific performance metrics or studies used to demonstrate this equivalence.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.
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