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510(k) Data Aggregation
(224 days)
ABX Pentra Micro ALB Control L/H is a quality control used to monitor the performance of ABX Pentra Micro ALBUMIN CP determination by immunoturbidimetry.
The ABX Pentra Micro ALB Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with added chemicals, constituents of human origin, stabilizers and preservatives. The assigned values and precise confidence interval are given in an enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the HORIBA clinical chemistry analyzer. Each control level is provided in one vial of 10 ml.
The provided text describes the ABX Pentra Micro ALB Control L/H, a quality control material used to monitor the performance of Microalbumin determination. The study described focuses on establishing the stability claims of this control rather than evaluating the performance of a diagnostic device in detecting a medical condition. Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are not applicable to this type of device and study.
Here's an analysis of the provided information concerning the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Shelf Life | 24 months at 2 to 8°C |
| Open Vial Stability | 90 days at 2 to 8°C |
| Performance Monitoring (Intended Use) | Monitors the performance of ABX Pentra Micro ALBUMIN CP determination by immunoturbidimetry. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a separate "test set" for an accuracy study. The stability studies (shelf life and open vial) would inherently involve testing multiple aliquots over time following specific protocols. The number of samples/replicates used in these stability studies is not detailed.
- Data Provenance: The study was conducted by HORIBA ABX SAS, located in Montpellier, France. The data appears to be prospective, collected for the purpose of demonstrating stability claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable as the device is a quality control material and the study focuses on its stability. "Ground truth" in the context of diagnostic accuracy (e.g., pathology, clinical outcomes) is not relevant here. The "ground truth" for a control material involves its assigned values, which are determined internally by the manufacturer through rigorous calibration and value assignment processes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the study is not evaluating a diagnostic device's performance against a clinical ground truth.
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 is a quality control material, not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a quality control material; there is no algorithm or human-in-the-loop performance to evaluate in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this control material is its assigned values and corresponding ±3SD confidence ranges, which are determined by the manufacturer (HORIBA ABX SAS) by calculating the mean value obtained from multiple determinations. This is a form of internal validation and characterization of the control material's expected performance.
8. The sample size for the training set
This is not applicable. This is a quality control material, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable.
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(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 |
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(56 days)
The ABX PENTRA Urine Cal is a calibrator for use in the calibration of the quantitative method : ABX PENTRA Urinary Proteins CP on ABX PENTRA 400 clinical chemistry analyzer as specified on the vials.
The calibrator included in this submission is for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer. The ABX PENTRA TPU Cal is a liquid calibrator based on a buffered aqueous solution, containing human serum. The assigned values of the calibrator components are given on the calibrator vials, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in three vials of 3 ml.
The provided document is a 510(k) Premarket Notification for a calibrator device (ABX PENTRA TPU Cal) used with a clinical chemistry analyzer. It is not a diagnostic imaging or AI-powered device, and therefore the requested information fields related to AI performance, such as sample size for test sets (including data provenance), number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of submission.
The document primarily focuses on demonstrating that the new calibrator (ABX PENTRA TPU Cal) is substantially equivalent to a predicate calibrator (ABX PENTRA Urine Cal) for the purpose of calibrating total proteins in urine measurements on the ABX PENTRA 400 analyzer.
Here's an analysis of the provided information, addressing the applicable points:
Acceptance Criteria and Reported Device Performance
The document states that "The performance testing data conclude that the safety and effectiveness of the device are not compromised, and that they met all acceptance criteria, demonstrating that the device is substantially equivalent to the predicate device." However, no specific quantitative acceptance criteria or detailed device performance metrics (e.g., accuracy, precision values) are explicitly listed in the provided text.
The acceptance criteria for a calibrator would typically relate to its stability, assigned values, and its ability to enable accurate and precise measurements when used with the associated assay and analyzer. The document implies these were met, but does not provide the specifics.
Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Demonstrate substantial equivalence to the predicate device (ABX PENTRA Urine Cal). | Performance testing data met all acceptance criteria, demonstrating substantial equivalence. (No specific quantitative metrics for comparison are provided in the document). |
| Stability (Closed) | Not explicitly stated, but implied to be sufficient for 24 months at 2-8°C. | 24 months at 2-8°C |
| Stability (Open) | Not explicitly stated, but implied to be sufficient for 9 weeks at 2-8°C. | 9 weeks at 2-8°C |
| Intended Use | Calibrate total proteins in urine measurement with reagent ABX Pentra Urinary Proteins CP on ABX PENTRA 400 analyzer. | Device is for this intended use. |
Study Details:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This is a calibrator, not an AI or diagnostic device that analyzes patient data. The "performance testing" mentioned would have involved laboratory studies on the calibrator's characteristics and its performance on the analyzer, not a test set of patient cases.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. Ground truth for patient cases is not relevant for a calibrator.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods for diagnostic test results are not relevant for a calibrator.
-
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:
- N/A. This is a calibrator, not an AI-assisted diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical calibrator solution, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. For a calibrator, "ground truth" would refer to the accurately assigned values of the analytes within the calibrator itself, established through reference methods and internal validation according to good manufacturing practices. The document states: "The assigned values of the calibrator components are given on the calibrator vials."
-
The sample size for the training set:
- N/A. This is a calibrator, not an AI model that requires a training set.
-
How the ground truth for the training set was established:
- N/A. Not applicable as there is no training set for a calibrator.
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(130 days)
ABX PENTRA Glucose HK CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
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 bench top clinical chemistry analyzer.
The ABX PENTRA Glucose HK CP is an in vitro diagnostic assay for the quantitative determination of glucose in human serum, plasma and urine based on an enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase. It is composed of a bi-reagent cassette, with 56 ml and 14 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Uric Acid CP is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). 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.
Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA Glucose HK CP and ABX PENTRA Uric Acid CP, focusing on the added urine sample performance. The ABX PENTRA Urine Control L/H is simply a control for these assays and its performance is described in terms of stability, not analytical performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (ABX PENTRA Glucose HK CP - Urine) | Reported Device Performance (ABX PENTRA Uric Acid CP - Urine) |
|---|---|---|---|
| Limit of Blank | Not explicitly stated | 1.95 mg/dl | 2.33 mg/dl |
| Limit of Detection | Not explicitly stated | 2.9 mg/dl | 3.49 mg/dl |
| Limit of Quantitation | Not explicitly stated | 3.3 mg/dl | 5.20 mg/dl |
| Accuracy and Precision | CV Total 0.99 (Implied, from context of "correlation coefficient") | r² = 0.997 (Y = 0.96 x + 0.84 mg/dl) | r² = 0.9949 (Y = 1.01 x + 0.99 mg/dl) |
| Calibration stability | Not explicitly stated | 21 days | 15 days |
| Reagent stability (closed) | Not explicitly stated | 36 months at 2-8°C | 36 months at 2-8°C |
| Reagent stability (on-board) | Not explicitly stated | 55 days (refrigerated area) | 41 days (refrigerated area) |
Note: The document states that the performance testing data demonstrated that the devices "met all acceptance criteria." However, explicit numerical acceptance criteria are not provided for all metrics. The reported performance values themselves serve as the demonstration of meeting internal acceptance criteria. For correlation, an R² value of >0.99 is generally considered excellent in such studies, hence the implied criterion. For CV Total, often
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(247 days)
The ABX PENTRA Urine Cal is a calibrator for use in the calibration of the quantitative method : ABX PENTRA Urinary Proteins CP on Horiba ABX PENTRA 400 clinical chemistry analyzer.
The calibrator included in this submission is for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer. The ABX PENTRA Urine Cal is a liquid calibrator based on a buffered aqueous solution, 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 three vials of 1 ml.
This document describes the premarket notification for the ABX PENTRA Urine Calibrator, a device intended for use on the ABX PENTRA 400 clinical chemistry analyzer to quantify total proteins in urine.
1. Acceptance Criteria and Reported Device Performance:
The document states that the performance testing data demonstrated that the device met all acceptance criteria, and its safety and effectiveness are not compromised. The specific, quantitative acceptance criteria are not explicitly detailed in the provided text, nor are specific performance metrics like accuracy, precision, or linearity values for the calibrator directly reported beyond the general statement of meeting criteria. The document primarily focuses on demonstrating substantial equivalence to a predicate device.
2. Sample Size for Test Set and Data Provenance:
The document does not specify the sample size used for the test set (performance testing) of the ABX PENTRA Urine Calibrator. It also does not mention the country of origin of the data or whether the study was retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth:
The document does not mention the use of experts to establish ground truth for the test set.
4. Adjudication Method:
The document does not mention any adjudication method for the test set. This is not typically relevant for a calibrator study.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not performed or reported. This type of study is not applicable for a device like a calibrator, which is evaluated for its analytical performance rather than impact on human reader interpretation.
6. Standalone Performance (Algorithm Only):
The device is a calibrator, not an algorithm, so a standalone performance study in the context of an "algorithm only" is not applicable. The performance testing described relates to the analytical performance of the calibrator itself and its interaction with the analyzer and reagent.
7. Type of Ground Truth Used:
The document does not explicitly state the type of "ground truth" used for performance testing. For a calibrator, the ground truth would typically be established by reference methods or gravimetric/volumetric analysis to assign precise values to the calibrator components. The document mentions "assigned values of the calibrator components are given in the enclosed annex," implying that these assigned values serve as the reference for performance evaluation.
8. Sample Size for Training Set:
The concept of a "training set" is typically associated with machine learning algorithms. Since the ABX PENTRA Urine Cal is a calibrator and not an AI/ML device, a training set in that context is not applicable and therefore not reported.
9. How Ground Truth for Training Set Was Established:
As there is no training set mentioned or applicable for this device, the method for establishing its ground truth is not applicable.
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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 |
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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.
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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 |
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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 |
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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
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