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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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