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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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(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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(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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