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510(k) Data Aggregation
(267 days)
ABX Pentra Calcium AS CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on a colourimetric method, using the ABX Pentra 400 Clinical Chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
All the reagent, controls and calibrator included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX Pentra Calcium AS CP is an in vitro diagnostic assay for the quantitative in vitro determination of calcium in human serum, plasma and urine based on colourimetric method. It is composed of a monoreagent cassette (79 mL). The reagent is chemical solution with additives.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer.
This calibrator is provided in ten vials of 3 ml.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
Here's a summary of the acceptance criteria and study details for the ABX PENTRA CALCIUM AS CP device and its associated controls and calibrators, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied/General Industry Practice for IVDs) | Reported Device Performance (ABX Pentra Calcium AS CP) |
|---|---|---|
| Detection Limit | (Not explicitly stated, but lower is better) | Serum/Plasma: 0.28 mg/dl; Urine: 0.23 mg/dl |
| Limit of Quantitation | (Not explicitly stated, but lower is better) | Serum/Plasma: 1.54 mg/dl; Urine: 0.64 mg/dl |
| Repeatability (CV%) | (Typically low CV% for good precision) | Serum/Plasma: • Control 1: 0.49% • Control 2: 0.37% • Specimen 1: 0.71% • Specimen 2: 0.40% • Specimen 3: 0.43% Urine: • Control 1: 0.62% • Control 2: 0.76% • Specimen 1: 0.46% • Specimen 2: 0.56% • Specimen 3: 0.37% |
| Reproducibility (CV%) | (Typically low CV% implying precision over time) | Serum/Plasma: • Control 1: 1.44% • Control 2: 1.49% • Specimen 1: 1.56% • Specimen 2: 1.54% • Specimen 3: 1.54% Urine: • Control 1: 1.45% • Control 2: 1.50% • Specimen 1: 1.57% • Specimen 2: 1.57% • Specimen 3: 1.56% |
| Measuring Range (Linearity) | (Demonstrate linearity within clinical range) | Serum/Plasma: 4.0 mg/dl - 18.05 mg/dl (up to 54.15 mg/dl with post-dilution); Urine: 0.64 mg/dl - 18.05 mg/dl (up to 54.15 mg/dl with post-dilution) |
| Method Comparison (Correlation with Reference) | (High correlation, ideally slope ≈ 1, intercept ≈ 0) | Serum/Plasma: Y = 1.00 x + 0.04 (mg/dl), r² = 0.9903 Urine: Y = 0.98 x -0.03 (mg/dl), r² = 0.993 |
| Matrix Comparison | (High correlation between serum and plasma) | Y = 1.006x - 0.0022, r² = 0.996 (for serum vs. lithium plasma) |
| Calibration Stability | (Period for which calibration holds) | 10 days (for serum/plasma and urine) |
| Reagent Stability | (Shelf-life and on-board stability) | Closed stability: 24 months at 2-8°C; On-board stability: 60 days at 2-8°C |
2. Sample Size Used for the Test Set and Data Provenance
- Detection Limit & Limit of Quantitation: Not specified for individual samples, but determined according to CLSI (NCCLS), EP17-A protocol.
- Repeatability (within-run precision):
- 3 specimens (low, medium, high concentration)
- 2 controls
- Each tested 20 times.
- Data provenance: Not explicitly stated, but likely from laboratory testing conducted by Horiba ABX SAS, France. Retrospective/Prospective is not specified.
- Reproducibility (total precision):
- 3 specimens (low, medium, high levels)
- 2 controls
- Each tested in duplicate for 20 days (2 series per day).
- Data provenance: Not explicitly stated, but likely from laboratory testing conducted by Horiba ABX SAS, France. Retrospective/Prospective is not specified.
- Method Comparison:
- Serum/Plasma: n = 145 patient samples
- Urine: n = 143 patient samples
- Data Provenance: Not explicitly stated beyond "patient samples," but implied to be from a clinical setting, likely in France given the company's location. Retrospective/Prospective is not fully specified, but patient samples are used to compare against a "commercial reagent taken as reference," suggesting a retrospective collection of samples for comparison.
- Matrix Comparison:
- n = 32 paired serum and lithium plasma samples (3 samples were altered)
- Data Provenance: Not explicitly stated beyond "samples," but implied to be from a clinical setting, likely in France. Retrospective/Prospective is not specified.
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 in vitro diagnostic (IVD) assays for quantitative chemical measurements. The "ground truth" for these studies is typically established by measurements from a well-characterized reference method or a predicate device, rather than expert consensus on images or clinical assessments. The studies performed here compare the device to a "commercial reagent taken as reference" (predicate device K061575) and uses established laboratory protocols (CLSI, Valtec).
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" is derived from quantitative measurements by reference methods, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance. This document describes a clinical chemistry analyzer and reagents, which do not involve human interpretation of images in the same way.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies described are standalone performance evaluations of the assay system (reagent and instrument). The performance metrics (detection limits, precision, linearity, method comparison, stability) reflect the algorithm's and the physical assay's performance without direct human interpretation influencing the measurement results. The human input is in setting up the system, running controls, and interpreting the numerical output, but the analytical measurement itself is automated.
7. Type of Ground Truth Used
- Reference Method/Predicate Device Comparison: For the method comparison study, the "ground truth" was established by measurements from a "commercial reagent taken as reference" (Olympus Calcium Arsenazo reagent, K061575).
- CLSI/NCCLS Protocols: Other performance parameters (detection limit, quantitation limit, precision, linearity) were evaluated against established CLSI/NCCLS and Valtec protocols, which define acceptable measurement performance characteristics. These protocols inherently define the "truth" in terms of statistical and analytical performance.
8. Sample Size for the Training Set
Not applicable. This device is a quantitative in vitro diagnostic reagent and assay system, not an AI/machine learning model that requires a training set in the conventional sense. The development of the reagents and assay parameters is based on chemical and analytical principles, and the performance is validated through the studies listed.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of IVD device.
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(431 days)
ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
All the reagent, controls and calibrator included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative in vitro determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a bi-reagent cassette (R1= 27.5 mL ; R2= 8 mL). Reagents are chemical solutions with additives.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
The provided text describes the acceptance criteria and performance data for the ABX PENTRA Creatinine 120 CP reagent and associated calibrators/controls, for use on the ABX PENTRA 400 clinical chemistry analyzer.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| ABX PENTRA Creatinine 120 CP (Reagent) | ||
| Detection limit (Serum/Plasma) | N/A (Comparison to predicate implies similar or better performance) | 0.074 mg/dl |
| Detection limit (Urine) | N/A | 1.40 mg/dl |
| Limit of Quantitation (Serum/Plasma) | N/A | 0.22 mg/dl |
| Limit of Quantitation (Urine) | N/A | 2.90 mg/dl |
| Accuracy and Precision (Serum/Plasma) | N/A (likely defined by an allowable CV% based on clinical standards or predicate) | CV. Total < 4.72% |
| Accuracy and Precision (Urine) | N/A | CV Total < 2.06% |
| Measuring range (Serum/Plasma) | N/A | 0.22 mg/dl - 18.08 mg/dl |
| Measuring range (Urine) | N/A | 2.90 mg/dl - 282.50 mg/dl |
| Upper linearity limit (Serum/Plasma) | N/A | 18.08 mg/dl (54.24 mg/dl with automatic post-dilution) |
| Upper linearity limit (Urine) | N/A | 282.5 mg/dl (847.50 mg/dl with automatic post-dilution) |
| Correlation (Serum/Plasma) | N/A (likely a high correlation coefficient with the predicate method) | Y = 0.99 x + 0.03 (mg/dl) with r2 = 0.9984 |
| Correlation (Urine) | N/A | Y = 1.00 x - 0.60 (mg/dl) with r2 = 0.9984 |
| Calibration stability (Serum/Plasma) | N/A (Standard stability duration for similar reagents) | 3 days |
| Calibration stability (Urine) | N/A | 3 days |
| Reagent stability (closed) | N/A | 36 months at 2-8°C |
| Reagent stability (on-board) | N/A | 19 days |
| ABX PENTRA Multical (Calibrator) | ||
| Stability (Closed) | N/A (Typical shelf-life for calibrators) | 24 months at 2-8°C |
| Stability (Open, general) | N/A (Typical in-use stability for calibrators) | 8 hours at 15-25°C; 2 days at 2-8°C; 2 weeks at -25 to -15°C |
| Stability (Open, Direct Bilirubin) | N/A | 3 hours at 15-25°C; 8 hours at 2-8°C; 2 weeks at -25 to -15°C |
| Stability (Open, Total Bilirubin) | N/A | 6 hours at 15-25°C; 1 day at 2-8°C |
| ABX PENTRA N Control (Control) | ||
| Stability (Closed) | N/A | 30 months at 2-8°C |
| Stability (Open, general) | N/A | 12 hours at 15-25°C; 5 days at 2-8°C; 1 month at -25 to -15°C |
| Stability (Open, Direct Bilirubin) | N/A | 4 hours at 15-25°C; 8 hours at 2-8°C; 2 weeks at -25 to -15°C |
| Stability (Open, Total Bilirubin) | N/A | 8 hours at 15-25°C; 1 day at 2-8°C; 2 weeks at -25 to -15°C |
| ABX PENTRA P Control (Control) | ||
| Stability (Closed) | N/A | 30 months at 2-8°C |
| Stability (Open, general) | N/A | 12 hours at 15-25°C; 5 days at 2-8°C; 1 month at -25 to -15°C |
| Stability (Open, Direct Bilirubin) | N/A | 4 hours at 15-25°C; 8 hours at 2-8°C; 2 weeks at -25 to -15°C |
| Stability (Open, Total Bilirubin) | N/A | 8 hours at 15-25°C; 1 day at 2-8°C; 2 weeks at -25 to -15°C |
| ABX PENTRA Urine Control L/H (Control) | ||
| Stability (Closed) | N/A | 2 years at 2-8°C |
| Stability (Open) | N/A | 30 days at 2-8°C |
Note: The document explicitly states "The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices." However, the exact numerical acceptance criteria values themselves (e.g., maximum allowable CV, minimum r2) for each parameter are not explicitly defined in the provided text, but are implied by the reported performance falling within acceptable ranges for substantial equivalence to the predicate devices.
2. Sample sizes used for the test set and the data provenance
- Creatinine 120 CP (Test Set):
- Serum/Plasma Correlation: n = 165
- Urine Correlation: n = 117
- Data Provenance: Not explicitly stated, but the company is Horiba ABX SAS, FRANCE, suggesting the data may originate from France or related study sites. The study is for premarket notification, implying prospective testing for device performance.
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 text. For in vitro diagnostic devices like this, ground truth is typically established by comparing performance to an established, often predicate, method or reference method, rather than through expert consensus in the way a medical imaging AI might use radiologists.
4. Adjudication method for the test set
- This information is not provided as it's not relevant for this type of in vitro diagnostic device performance study. Performance is assessed quantitatively against a reference method or specified analytical limits.
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 information is not applicable/not provided. This is an in-vitro diagnostic assay and associated controls/calibrators, not an AI-assisted diagnostic tool that involves human readers interpreting results.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is a standalone diagnostic assay (reagent, calibrator, control) for use on an automated clinical chemistry analyzer (ABX PENTRA 400). The performance data presented (detection limits, accuracy, precision, measuring range, correlation, stability) reflect the standalone analytical performance of the device on the analyzer. There is no "human-in-the-loop" component for the measurement process itself beyond loading samples and reagents.
7. The type of ground truth used
- For the ABX PENTRA Creatinine 120 CP reagent, the ground truth for correlation studies was established by comparing its measurements (Y) against those of the predicate device/method (X), as indicated by the correlation equations (e.g., "Y = 0.99 x + 0.03"). This implies a comparative method ground truth (i.e., comparison against a legally marketed, established method).
- For the calibrators and controls, the "assigned values" of their components serve as their reference values or ground truth, established through rigorous manufacturing and value assignment processes.
8. The sample size for the training set
- This information is not provided. This type of in vitro diagnostic device is chemically based and does not typically involve a "training set" in the machine learning sense. The development likely involves extensive R&D and analytical validation, but not a distinct "training set" of patient data for a learning algorithm.
9. How the ground truth for the training set was established
- This information is not applicable as there is no "training set" in the context of this device's development as described.
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(204 days)
ABX PENTRA Enzymatic Creatinine CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on an enzymatic method using a multi-step approach ending with a photometric end-point reaction. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
All the reagent, controls and calibrator included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA Enzymatic Creatinine CP is an in vitro diagnostic assay for the quantitative in vitro determination of creatinine in human serum, plasma and urine based on an enzymatic method using a multi-step approach ending with a photometric end-point reaction. It is composed of a bi-reagent cassette (R1= 22 mL ; R2= 8 mL). Reagent is a chemical solution with additives.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexe, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
The provided text describes performance data for the ABX PENTRA Enzymatic Creatinine CP reagent, along with associated calibrators and controls, for use on the ABX PENTRA 400 clinical chemistry analyzer. The study aims to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents performance data for the ABX PENTRA Enzymatic Creatinine CP reagent, which implicitly serve as acceptance criteria for its clearance.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Detection Limit | Not explicitly stated as acceptance criteria, but reported values are key performance indicators. | Serum/Plasma: 0.026 mg/dlUrine: 0.66 mg/dl |
| Limit of Quantitation | Not explicitly stated as acceptance criteria, but reported values are key performance indicators. | Serum/Plasma: 0.11 mg/dlUrine: 1.71 mg/dl |
| Accuracy and Precision | Total CV for Serum/Plasma < 4.12%Total CV for Urine < 4.84% | Serum/Plasma CV Total < 4.12%Urine CV Total < 4.84% |
| Measuring Range | Not explicitly stated as acceptance criteria, but reported values are key performance indicators. | Serum/Plasma: 0.11 mg/dl - 16.95 mg/dlUrine: 3.56 mg/dl - 175 mg/dl |
| Upper Linearity Limit | Not explicitly stated as acceptance criteria, but reported values are key performance indicators. | Serum/Plasma: 16.95 mg/dl (50.85 mg/dl with auto post-dilution)Urine: 175 mg/dl (525 mg/dl with auto post-dilution) |
| Correlation | High correlation (r²) close to 1 with predicate (or reference) method. | Serum/Plasma (n=153): Y = 1.00 x + 0.00 (mg/dl) with r² = 0.999.Urine (n=105): Y = 0.97 x - 0.33 (mg/dl) with r² = 0.9982. |
| Calibration Stability | Serum/Plasma: 14 daysUrine: 14 days | Serum/Plasma: 14 daysUrine: 14 days |
| Reagent Stability | Closed: 18 months at 2-8°COn-board: 30 days | Closed: 18 months at 2-8°COn-board: 30 days |
For the calibrators (ABX PENTRA Multical) and controls (ABX PENTRA N Control, ABX PENTRA P Control, ABX PENTRA Urine Control L/H), the acceptance criteria relate to their stability (closed and open vial) and their ability to ensure optimal calibration and control of the methods. The document reports specific stability periods for each.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For Correlation testing (Creatinine CP reagent):
- Serum/Plasma: n=153
- Urine: n=105
- The sample sizes for other performance metrics (detection limit, limit of quantitation, accuracy, precision, measuring range, linearity, stability) are not explicitly stated in the provided text. They are summarized, but the number of unique samples used to establish these values is not detailed.
- For Correlation testing (Creatinine CP reagent):
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable to this type of device and study. The device is a clinical chemistry reagent for quantitative determination, not a diagnostic imaging or AI device requiring expert interpretation for ground truth establishment. The ground truth here would be established by a reference method (the predicate device K070383 for Creatinine) or a recognized laboratory standard.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., radiologists interpreting images) to resolve discrepancies and establish a consensus ground truth. For a quantitative chemical assay, the comparison is against an established reference method.
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 information is not applicable to this type of device and study. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic interpretation, which is not the function of a clinical chemistry reagent.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an algorithm in the AI sense. This device is a reagent system that performs quantitative chemical analysis. The performance data presented (accuracy, precision, correlation, etc.) is the standalone performance of the reagent system on the analyzer, without human interpretation as a performance metric.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the Creatinine CP reagent, the ground truth for performance evaluation (specifically correlation) would have been established by comparing the results obtained using the new device against results from a legally marketed predicate device (K070383) or a recognized reference method. The "Y = 1.00 x + 0.00 (mg/dl)" correlation equations suggest a comparison against a reference method, where 'x' represents the reference method's result.
For the calibrators and controls, the "assigned values" for their components are the ground truth, ensuring optimal calibration and control. These values are established through rigorous testing and standardization, often traceable to international reference materials.
8. The Sample Size for the Training Set
This information is not explicitly provided in the summary. For a medical device like a chemical reagent, the "training set" concept is not directly analogous to machine learning. However, the development and optimization of the reagent formulation and methods would involve extensive internal testing using numerous samples to establish the assay's characteristics before formal validation studies. The provided summary focuses on the validation data.
9. How the Ground Truth for the Training Set Was Established
As mentioned in point 8, the concept of a "training set" and its "ground truth" establishment isn't directly applicable in the same way as AI/ML devices. For a chemical reagent, the development process would involve:
- Reference Methods: Using established, highly accurate reference methods or certified reference materials to determine the true values of analytes in samples used during development.
- Standardization: Developing and refining the assay chemistry to consistently achieve accurate and precise measurements against these reference values.
- Specifications: Establishing performance specifications based on clinical requirements and comparison to existing, cleared methods.
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(121 days)
Creatinine and Total Protein reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.
ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
ABX PENTRA Total Protein 100 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA Total Protein 100 CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 28 ml mono-reagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels.
Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA Creatinine 120 CP and ABX PENTRA Total Protein 100 CP devices, based on the provided text:
Acceptance Criteria and Device Performance
The devices are in vitro diagnostic assays, and their performance is described in terms of analytical characteristics. The stated performance data implicitly serve as the acceptance criteria for the devices to be considered substantially equivalent to their predicate devices.
ABX PENTRA Creatinine 120 CP
| Acceptance Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sample type | Serum, Plasma and Urine compatibility | Serum, Plasma and Urine |
| Detection limit | Specified limits for serum/plasma and urine | Serum/Plasma: 0.18 mg/dl; Urine: 1.39 mg/dl |
| Accuracy and Precision | CV Total below specified percentages | Serum/Plasma CV Total < 5.83%; Urine CV Total < 6.00% |
| Measuring range | Specified ranges for serum/plasma and urine | Serum/Plasma: 0.18 mg/dl - 22.60 mg/dl; Urine: 1.39 mg/dl - 282.5 mg/dl |
| Upper linearity limit | Specified limits with and without automatic post-dilution | Serum/Plasma: 22.60 mg/dl (67.8 mg/dl with post-dilution); Urine: 282.5 mg/dl (857.5 mg/dl with post-dilution) |
| Correlation | High correlation coefficient (r²) and slope/intercept close to ideal line (Y=X) | Serum/Plasma (n=122): Y = 0.98 x - 0.04 with r² = 0.9991; Urine (n=119): Y = 0.96 x - 0.73 with r² = 0.9975 |
| Calibration stability | Specified stability period | Serum/Plasma: 24 hours; Urine: 24 hours |
| Reagent stability | Specified closed and on-board stability | closed stability: 24 months at 2-8°C; on-board stability: 10 days |
ABX PENTRA Total Protein 100 CP
| Acceptance Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sample type | Serum/Plasma compatibility | Serum/Plasma |
| Detection limit | Specified limit | 0.01 g/dl |
| Accuracy and Precision | CV Total below specified percentage | CV Total < 1.62% |
| Measuring range | Specified range | 0.10 g/dl – 10.0 g/dl |
| Upper linearity limit | Specified limit with and without automatic post-dilution | 10.0 g/dl (20.0 g/dl with automatic post-dilution) |
| Correlation | High correlation coefficient (r²) and slope/intercept close to ideal line (Y=X) | Y = 1.03 x - 0.20 with a correlation coefficient r² = 0.9921 |
| Calibration stability | Specified stability period | 1 day |
| Reagent stability | Specified closed and on-board stability | closed stability: 26 months at 2-25°C; on-board stability: 14 days |
Study Information
The document describes the performance data for in vitro diagnostic reagents. The studies performed are analytical performance studies, not clinical studies involving human patients or ground truth established by medical experts for diagnostic interpretation.
-
Sample size used for the test set and the data provenance:
- ABX PENTRA Creatinine 120 CP:
- Serum/Plasma correlation study: n=122 samples.
- Urine correlation study: n=119 samples.
- ABX PENTRA Total Protein 100 CP:
- Correlation study: n=178 samples.
- Data Provenance: The document states "HORIBA ABX, FRANCE" as the company location, implying the studies were conducted or samples sourced from France. The data is retrospective in the sense that it's laboratory performance data generated to characterize the assay, not new prospective patient data collected for a clinical trial.
- ABX PENTRA Creatinine 120 CP:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For in vitro diagnostic reagents, "ground truth" is typically established by reference methods or validated comparative assays. The correlation studies are comparing the performance of the new device against a comparative method. The text does not specify the comparative method used, nor does it mention any human experts establishing ground truth for these analytical measurements.
-
Adjudication method for the test set:
- Not applicable. Analytical studies for these types of reagents do not typically involve human adjudication of results. The "truth" or reference values for the samples would be determined by the comparative method.
-
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. These are in vitro diagnostic reagents that measure chemical analytes. They are not AI-powered image analysis devices or clinical decision support tools that would involve human readers or AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, these are standalone analytical performance studies of reagents and their performance on an automated analyzer (ABX PENTRA 400). The "algorithm" here refers to the chemical reaction and measurement process of the diagnostic assay itself. Human intervention is limited to sample loading, instrument operation, and quality control, but the measurement itself is automated.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these analytical performance studies is implicitly the results obtained from a comparative method or reference method against which the new device's measurements are correlated. The document states "Correlation" with r² values, indicating a comparison against another measurement method. The nature of this comparative method (e.g., another FDA-cleared creatinine assay) is not explicitly detailed but is standard practice for IVD submissions.
-
The sample size for the training set:
- Not applicable. These are chemical reagents following established principles (Jaffé method, Biuret reaction). They are not machine learning or AI-based algorithms that require "training sets" in the conventional sense. The development of such reagents involves extensive research and development, but not "training data" in the AI context.
-
How the ground truth for the training set was established:
- Not applicable (as explained above).
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(269 days)
ABX PENTRA Urea CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and qlutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA Urea CP is an in vitro diagnostic assay for the quantitative determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and glutamate dehydrogenase. It is composed of a bi-reagent cassette, with 60 ml and 15 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
The provided 510(k) summary describes the acceptance criteria and performance study for the ABX PENTRA Urea CP reagent (for urine samples) and ABX PENTRA Urine Control L/H.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Device: ABX PENTRA Urea CP (for urine samples)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detection Limit | Urea: 12.6 mmol/l |
| BUN: 35 mg/dl | |
| Accuracy and Precision | CV Total < 7.50% |
| Measuring Range | Urea: 12.6 - 750.0 mmol/l |
| BUN: 35 - 2106 mg/dl | |
| Upper Linearity Limit | Urea: 750 mmol/l (3750 mmol/l with automatic post-dilution) |
| BUN: 35 mg/dl (2106 mg/dl with automatic post-dilution) | |
| Correlation | Urea: $Y = 1.13 x - 0.71$ with $r^2 = 0.9947$ |
| BUN: $Y = 1.13 x - 2.08$ with $r^2 = 0.9947$ | |
| Calibration Stability | 8 days |
| Reagent Stability | Closed: 24 months at 2-8°C |
| On-board: 70 days |
Device: ABX PENTRA Urine Control L/H
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analytes Covered | Amylase, Calcium, Creatinine, Phosphorus, Urea / Blood Urea Nitrogen, Urinary proteins (some were already cleared, Urea/BUN is included in this submission). |
| Format | Liquid solution prepared from human urine with chemical additives and materials of biological origin. |
| Stability | Closed: 2 years at 2-8°C |
| Open: 30 days at 2-8°C |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For the Correlation study of ABX PENTRA Urea CP (urine samples),
n=147samples were used. - No specific sample size is explicitly stated for other performance metrics (Detection Limit, Accuracy, Precision, Measuring Range, Linearity, Stability) but these are typically tested with a sufficient number of replicates and samples to satisfy internal validation protocols.
- For the Correlation study of ABX PENTRA Urea CP (urine samples),
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies described are for an in vitro diagnostic (IVD) reagent and control, where "ground truth" often refers to reference methods or comparative assays, not expert consensus in the same way it would for imaging diagnostics.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation by multiple human readers, not for analytical performance testing of biochemical assays.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided. MRMC studies are relevant for imaging devices or software that assist human interpretation. This submission is for an in vitro diagnostic reagent and control.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The performance data presented is for the reagent and control used on the ABX PENTRA 400 analyzer, which is an automated clinical chemistry analyzer. Therefore, the reported performance metrics (detection limit, accuracy, precision, measuring range, linearity, correlation, stability) represent the standalone performance of the device system (reagent + analyzer) without human interpretive input. The product is not an "algorithm" in the sense of AI/ML, but a chemical test system.
7. Type of Ground Truth Used
For the Correlation study of ABX PENTRA Urea CP, the reported correlation coefficients ($r^2$) and linear equations imply a comparison against a reference method or predicate device's results (denoted as 'x' in the equations). The document does not explicitly name the reference method, but states the device demonstrates "substantial equivalence to their respective predicate devices."
For the other analytical performance characteristics (Detection Limit, Accuracy, Precision, Measuring Range, Linearity, Stability), the "ground truth" would be established through a combination of:
- Use of reference materials or calibrators with known analyte concentrations.
- Comparison with established laboratory methods or predicate devices.
- Internal validation procedures demonstrating adherence to pre-defined specifications.
8. Sample Size for the Training Set
This information is not provided and not applicable in the context of this traditional IVD product. Training sets are typically associated with machine learning or AI-based devices. This submission describes a chemical reagent and control.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and not applicable as there is no "training set" in the context of this device.
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(272 days)
Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.
ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test.
Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy.
The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods.
ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoqlobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay.
Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA CK NAC CP is an in vitro diagnostic assay for the quantitative determination of total creatine kinase in human serum and plasma based on an optimized UV test. The assay is composed of a bi-reagent cassette, with 26 ml and 6.5 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Myoglobin CP is an in vitro diagnostic assay for the quantitative determination of myoglobin in human serum and plasma based on a latex-enhanced immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 15 ml and 9.5 ml compartments. Reagents are chemical solutions with chemical additives and substances of animal origin.
The ABX PENTRA Myoglobin Cal is a liquid calibrator prepared from a dilution of purified myoglobin positive human sera. It is used for the calibration of the myoglobin assay. The assigned values are given on the vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA CK Control is a lyophilized assayed control prepared from a bovine serum albumin with chemical additives and material of biological origin. It has to be used for the quality control of the creatine kinase assay. The assigned values are given in the enclosed annex. This calibrator is provided in 4 vials of 3 ml.
The ABX PENTRA Immuno II Control L/H is a lyophilized assayed control prepared from a stabilized pool of human sera. It has 2 levels (Low and High) to be used for the quality control of the myoglobin assay. The assigned values are given in the enclosed annex. Each level of this control is provided in one vial of 3 ml.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
This submission describes various reagents, controls, and calibrators for in vitro diagnostic use with the Horiba ABX Pentra 400 clinical chemistry analyzer. The performance data focuses on establishing substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily performance characteristics of the various reagents, controls, and calibrators.
ABX PENTRA CK NAC CP (Reagent for Total Creatine Kinase)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 8 U/l |
| Accuracy and Precision | CV Total < 4.65% |
| Measuring range | 8 U/l - 1500 U/l |
| Upper linearity limit | 1500 U/l, and with automatic post-dilution: 4500 U/l |
| Correlation (n=350) | Y = 1.05 x - 1.75 with a correlation coefficient r² = 0.9930 |
| Calibration stability | 8 days |
| Reagent stability (closed) | 18 months at 2-8°C |
| Reagent stability (on-board) | 64 days (refrigerated area) |
ABX PENTRA Myoglobin CP (Reagent for Myoglobin)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 6.7 µg/l |
| Accuracy and Precision | CV Total < 5.24% |
| Measuring range | 20.7 µg/l – 500 µg/l |
| Upper linearity limit | 500 µg/l |
| Correlation (n=180) | Y = 0.94 x + 19.44 with a correlation coefficient r² = 0.9756 |
| Calibration stability | 21 days |
| Reagent stability (closed) | 12 months at 2-8°C |
| Reagent stability (on-board) | 35 days (refrigerated area) |
ABX PENTRA Myoglobin Cal (Calibrator)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analytes | Myoglobin |
| Format | Liquid preparation of diluted purified myoglobin positive human sera: 5 levels |
| Stability (closed) | 12 months at 2°C to 10°C |
| Stability (open) | 7 weeks at 2°C to 10°C |
ABX PENTRA Multical (Calibrator)
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Analytes | Various, including Creatine kinase (included in this submission) |
| Format | Lyophilized human serum with chemical additives and materials of biological origin |
| Stability (closed) | 24 months at 2-8°C |
| Stability (open) | General components: 8 hours at 15-25°C, 2 days at 2-8°C, 2 weeks at -25- -15°C Direct Bilirubin: 3 hours at 15-25°C, 8 hours at 2-8°C, 2 weeks at -25- -15°C Total Bilirubin: 6 hours at 15-25°C, 1 day at 2-8°C, 2 weeks at -25- -15°C |
ABX PENTRA CK Control (Control)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analytes | Total Creatine Kinase |
| Format | Lyophilized preparation of bovine serum albumin with chemical additives and material of animal origin |
| Stability (closed) | 18 months at 2°C to 8°C |
| Stability (open) | 24 hours at 15°C to 25°C, 3 days at 2°C to 8°C |
ABX PENTRA Immuno II Control L/H (Control)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analytes | Myoglobin |
| Format | Lyophilized preparation of bovine serum albumin with chemical additives and material of animal origin |
| Stability (closed) | 18 months at 2°C to 10°C |
| Stability (open) | 2 weeks at 2°C to 10°C, 3 months at -20°C |
ABX PENTRA N Control and ABX PENTRA P Control (Controls)
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Analytes | Various, including Creatine kinase (N Control, P Control) |
| Format | Lyophilized human serum with chemical additives and materials of biological origin |
| Stability (closed) | 30 months at 2-8°C |
| Stability (open) | General components: 12 hours at 15-25°C, 5 days at 2-8°C, 1 month at -25- -15°C Direct Bilirubin: 4 hours at 15-25°C, 8 hours at 2-8°C, 2 weeks at -25- -15°C Total Bilirubin: 8 hours at 15-25°C, 1 day at 2-8°C, 2 weeks at -25- -15°C |
2. Sample Size Used for the Test Set and Data Provenance
- ABX PENTRA CK NAC CP: Correlation study used n=350 samples.
- ABX PENTRA Myoglobin CP: Correlation study used n=180 samples.
- Data Provenance: Not explicitly stated, but the submission is from Horiba ABX, France. Given the nature of in vitro diagnostic device submissions for a global market, it is common for such studies to be conducted internally or at contract research organizations, potentially in the country of origin (France) or other locations. The document does not specify if the data is retrospective or prospective, but performance data for new IVD products is typically generated prospectively, though some method comparison might involve retrospective samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As an in vitro diagnostic device for quantitative determination of analytes, "ground truth" is typically established by reference methods or predicate devices, not by expert interpretation of images or clinical cases. The "experts" in this context would be the laboratory personnel performing the reference method assays or clinical chemists validating the results. Their qualifications are not detailed in this submission.
4. Adjudication Method for the Test Set
Not applicable. This is for an in vitro diagnostic assay, not a medical imaging or diagnostic interpretation device requiring adjudication of expert opinions. Performance is assessed through quantitative measurements, precision, accuracy, linearity, and correlation with predicate devices.
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 not an AI-assisted diagnostic device. It's a collection of reagents, controls, and calibrators for a chemistry analyzer.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
Not applicable for an IVD reagent/calibrator/control submission. The device performs a quantitative measurement on an automated analyzer. Its performance is inherently "standalone" in the sense that the analyzer and reagents perform the test without human interpretive input for the result itself. Human involvement is in sample handling, loading, running, and interpreting the numerical result in a clinical context.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the performance studies (accuracy, correlation), the "ground truth" is established by comparison to results obtained from predicate devices (as detailed in the substantial equivalence table) or established reference methods. For example, the correlation studies show the device's results (Y) compared to a reference method or predicate device's results (x). Precision and linearity are evaluated against expected analytical performance criteria.
8. The Sample Size for the Training Set
Not applicable. These are chemical reagents, controls, and calibrators for an in vitro diagnostic assay, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this type of device.
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(469 days)
Proteins reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.
ABX PENTRA Albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry.
Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
ABX PENTRA Total Protein CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
ABX PENTRA Micro-albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Albumin in urine (µALB) at low concentration by immunoturbidimetric assay.
Measurements of albumin aids in the diagnosis of diabetic nephritis and other kidney and intestinal diseases.
The ABX PENTRA µ-Alb Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Micro-albumin CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA u-Alb Control L/H is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA Micro-albumin CP method.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA Albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum and plasma based on a colorimetric test using Bromocresol Green (BCG). It is composed of a 99 ml mono-reagent cassette.
The ABX PENTRA Total Protein CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 61 ml mono-reagent cassette.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
The ABX PENTRA Micro-albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human urine based on an immunoturbidimetric test. It is composed of a bi-reagent cassette, with 19 ml and 4.5 ml compartments.
The ABX PENTRA u-Alb Cal is a liquid calibrator prepared by adding purified human albumin to a chemical buffer solution. It has 5 levels to be used for the calibration of the urinary albumin assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA u-Alb Control L/H is a liguid assayed control prepared by adding purified human albumin to a chemical buffer solution. It has 2 levels (Low and High) to be used for the quality control of the urinary albumin assay. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 1 ml.
The provided text describes performance data for a set of reagents, controls, and calibrators used with the ABX PENTRA 400 clinical chemistry analyzer. The studies conducted are in vitro diagnostic assay performance evaluations, not studies involving human readers or clinical outcomes in the same way an AI-powered diagnostic device would be evaluated. As such, several requested items (MRMC study, expert ground truth, adjudication methods) are not applicable to this type of submission.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The provided tables summarize the performance characteristics. The document states that "The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices." While specific numeric acceptance criteria for each metric (e.g., "CV Total must be < X%") are not explicitly listed, the "Reported Device Performance" column represents the results achieved, which are implied to have met the predefined criteria for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
| Device/Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| ABX PENTRA Albumin CP | - | Sample type: Serum & plasmaDetection limit: 0.02 g/dlAccuracy and Precision: CV Total < 1.86%Measuring range: 0.46 g/dl – 5.60 g/dlUpper linearity limit: 5.60 g/dl, with automatic post-dilution: 11.20 g/dlCorrelation (n=272): Y = 0.94 x + 0.01 with r² = 0.9864Calibration stability: 14 daysReagent stability: closed 36 months (2-8°C), on-board 83 days (refrigerated area) |
| ABX PENTRA Micro-albumin CP | - | Sample type: UrineDetection limit: 4 mg/lAccuracy and Precision: CV Total < 7.99%Measuring range: 9.0 mg/l – 200 mg/lUpper linearity limit: 200 mg/l, with automatic post-dilution: 2000 mg/lCorrelation (n=252): Y = 0.91 x + 3.95 with r² = 0.9919Calibration stability: 7 daysReagent stability: closed 24 months (2-8°C), on-board 23 days (refrigerated area) |
| ABX PENTRA Total Protein CP | - | Sample type: Serum & plasmaDetection limit: 0.14 g/dlQuantitation limit: 0.60 g/dlAccuracy and Precision: CV Total < 2.82%Measuring range: 0.60 g/dl - 10 g/dlUpper linearity limit: 10 g/dl, with automatic post-dilution: 20 g/dlCorrelation: Serum (n=230): Y = 1.03 x + 0.02 with r² = 0.9841. Plasma (n=262): Y = 0.98 x - 0.02 with r² = 0.9815.Calibration stability: 1 dayReagent stability: closed 36 months (2-8°C), on-board 6 days (refrigerated area) |
| ABX PENTRA µ-Alb Cal | - | Analyte: AlbuminFormat: Purified human albumin added to a chemical buffer solutionStability: Closed 12 months (2-10°C), Open 4 weeks (2-10°C), 3 months (-20°C) |
| ABX PENTRA Multical | - | Analytes: Various (as listed)Format: Lyophilized human serum with chemical additives and materials of biological originStability: Closed 24 months (2-8°C), Open: 8h (15-25°C), 2 days (2-8°C), 2 weeks (-25 to -15°C) (exceptions for Direct/Total Bilirubin) |
| ABX PENTRA µ-Alb Control | - | Analyte: AlbuminFormat: Purified human albumin added to a chemical buffer solutionStability: Closed 12 months (2-10°C), Open 4 weeks (2-10°C) |
| ABX PENTRA N Control | - | Analytes: Various (as listed)Format: Lyophilized human serum with chemical additives and materials of biological originStability: Closed 30 months (2-8°C), Open: 12h (15-25°C), 5 days (2-8°C), 1 month (-25 to -15°C) (exceptions for Direct/Total Bilirubin) |
| ABX PENTRA P Control | - | Analytes: Various (as listed)Format: Lyophilized human serum with chemical additives and materials of biological originStability: Closed 30 months (2-8°C), Open: 12h (15-25°C), 5 days (2-8°C), 1 month (-25 to -15°C) (exceptions for Direct/Total Bilirubin) |
(Note: "Acceptance Criteria (Implied)" is marked as '-' because specific target values for each metric were not explicitly stated in the provided text, only that the reported performance "met all acceptance criteria.")
2. Sample size used for the test set and the data provenance:
- ABX PENTRA Albumin CP:
- Test Set Sample Size: n=272 for correlation study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Standard in vitro diagnostic assay validation typically uses a mix of native human samples, spiked samples, and control materials.
- ABX PENTRA Micro-albumin CP:
- Test Set Sample Size: n=252 for correlation study.
- Data Provenance: Not explicitly stated.
- ABX PENTRA Total Protein CP:
- Test Set Sample Size: n=230 for serum samples and n=262 for plasma samples in correlation studies.
- Data Provenance: Not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not an imaging or diagnostic AI device requiring expert interpretation of clinical data for ground truth. The "ground truth" for these assays would typically be established by reference methods or validated comparative methods, and the accuracy evaluated against those.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As per point 3, there is no expert adjudication process involved for establishing ground truth in this type of in vitro assay performance study.
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 not an AI/human-in-the-loop diagnostic device but a chemical analyzer with associated reagents, controls, and calibrators.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The performance data presented (accuracy, precision, linearity, stability, correlation) are for the device (reagent/analyzer system) operating in a standalone analytical capacity. The "performance data" discussed are the results generated solely by the ABX PENTRA 400 system using these components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the correlation studies ("Y = ... x + ... with a correlation coefficient r² = ..."), the device's measurements (Y) are being correlated against measurements from another method (x), which serves as the comparative or "ground truth" method. The text does not explicitly name the specific comparative methods used for albumin, micro-albumin, and total protein but relies on the concept of "substantial equivalence" to predicate devices, implying these predicate devices' methods serve as the benchmark. Precision, linearity, and stability are evaluated intrinsically against standardized methods and statistical metrics.
8. The sample size for the training set:
- Not Applicable in the context of machine learning. These are chemical assays, not machine learning algorithms that require explicit "training sets" in the modern AI sense. The development of such assays involves formulation optimization and internal validation, which could be considered analogous, but the term "training set" doesn't directly apply.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8. The "ground truth" for developing and validating these types of assays involves adherence to established chemical principles, analytical standards, and comparison to validated reference measurement procedures or existing, legally marketed predicate devices.
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