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510(k) Data Aggregation
(148 days)
ABX PENTRA Cholesterol CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
ABX PENTRA HDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of High Density Lipoprotein Cholesterol (HDL-C) in human serum and plasma based on an enzymatic assay with accelerator selective detergent methodology.
ABX PENTRA LDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and plasma based on an enzymatic colorimetric assay.
ABX PENTRA Triglycerides CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of triglycerides in human serum and plasma based on an enzymatic colorimetric assay. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
The ABX PENTRA HDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HDL Direct CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA LDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA LDL Direct CP method on Horiba ABX clinical chemistry analyzers.
All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of their respective analytes : Cholesterol, HDL-C. LDL-C and Triglycerides using human serum and plasma. The controls, calibrators and additional reagents are intended for use in association with the above reagents.
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 Cholesterol CP is an in vitro diagnostic assay for the quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of High Density Lipoprotein Cholesterol (HDL-C) in human serum and plasma based on an enzymatic test, with accelerator selective detergent methodology. The assay is composed of a bi-reagent cassette, with 62 ml and 21 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and plasma based on an enzymatic colorimetric test. It is composed of a bi-reagent cassette, with 28 ml and 10 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Triglycerides CP is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA HDL Cal is a lyophilized calibrator prepared from human serum. It is used for the calibration of the HDL-C assay. The assigned value is given in the enclosed annex. This calibrator is provided in two vials of 1 ml.
The ABX PENTRA LDL Cal is a lyophilized calibrator prepared from human serum. It is used for the calibration of the LDL-C assay. The assigned value is given in the enclosed annex. This calibrator is provided in two vials of 1 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.
The ABX PENTRA Clean-Chem CP and ABX PENTRA Clean-Chem 99 CP are ready-to-use chemical cleaning solutions for use on the ABX Pentra 400 system. They are respectively provided in mono-reagent 30 ml and 4 x 99 ml cassettes.
This submission pertains to the Horiba ABX PENTRA line of reagents, calibrators, and controls for use with the ABX PENTRA 400 Clinical Chemistry Analyzer. The performance data discussed focuses on the quantitative determination of Cholesterol, HDL-C, LDL-C, and Triglycerides in human serum and plasma.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for each analyte are implicitly defined by the reported performance claims. The study demonstrates that the devices met these criteria.
ABX PENTRA Cholesterol CP:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sample Type | Serum & plasma |
| Detection Limit | 4 mg/dl |
| Accuracy and Precision | CV Total < 3.01% |
| Measuring Range | 2.55 mg/dl - 583.26 mg/dl |
| Upper Linearity Limit | 580 mg/dl |
| Correlation (vs. Predicate) | Y = 0.95x + 1.90, r² = 0.9943 (n=135) |
| Calibration Stability | 8 days |
| Reagent Stability | Closed: 24 months at 2-8°C; On-board: 48 days |
ABX PENTRA HDL Direct CP:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sample Type | Serum & plasma |
| Detection Limit | 1.16 mg/dl |
| Accuracy and Precision | CV Total < 3.52% |
| Measuring Range | 5.4 mg/dl - 151.9 mg/dl |
| Upper Linearity Limit | 154.8 mg/dl |
| Correlation (vs. Predicate) | Y = 0.91x + 1.98, r² = 0.9768 (n=121) |
| Calibration Stability | 14 days |
| Reagent Stability | Closed: 22 months at 2-8°C; On-board: 31 days |
ABX PENTRA LDL Direct CP:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sample Type | Serum & plasma |
| Detection Limit | 1.55 mg/dl |
| Accuracy and Precision | CV Total < 6.39% |
| Measuring Range | 1.35 mg/dl - 369.39 mg/dl |
| Upper Linearity Limit | 387 mg/dl |
| Correlation (vs. Predicate) | Y = 0.96x - 0.21, r² = 0.9963 (n=122) |
| Calibration Stability | 12 days |
| Reagent Stability | Closed: 18 months at 2-8°C; On-board: 97 days |
ABX PENTRA Triglycerides CP:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sample Type | Serum & plasma |
| Detection Limit | 7 mg/dl |
| Accuracy and Precision | CV Total < 2.83% |
| Measuring Range | 3.1 mg/dl - 1434 mg/dl |
| Upper Linearity Limit | 1470 mg/dl (5580 mg/dl with auto post-dilution) |
| Correlation (vs. Predicate) | Y = 0.99x + 0.20, r² = 0.9994 (n=135) |
| Calibration Stability | 14 days |
| Reagent Stability | Closed: 16 months at 2-8°C; On-board: 48 days |
2. Sample Size and Data Provenance
- Cholesterol CP: Test set sample size: 135
- HDL Direct CP: Test set sample size: 121
- LDL Direct CP: Test set sample size: 122
- Triglycerides CP: Test set sample size: 135
The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the manufacturer is Horiba ABX, France, it is likely the studies were conducted in France or a European context. The data appears to be derived from analytical performance studies, which are typically prospective in nature for device validation.
3. Number and Qualifications of Experts for Ground Truth
This information is not provided in the given document. The ground truth for these types of in vitro diagnostic devices usually refers to a reference method or a legally marketed predicate device against which the new device's performance is correlated, rather than expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the given document. Adjudication methods like 2+1 or 3+1 typically apply to studies involving human readers interpreting medical images or clinical data, which is not the nature of this in vitro diagnostic device study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided in the given document. MRMC studies are used to evaluate human reader performance with and without AI assistance, which is not relevant for an in vitro diagnostic reagent and calibrator kit.
6. Standalone (Algorithm Only) Performance Study
The performance data presented, including correlation, accuracy, precision, detection limit, measuring range, and linearity, represents the standalone performance of the ABX PENTRA reagents and calibrators when used with the ABX PENTRA 400 Clinical Chemistry Analyzer. The "algorithm" in this context refers to the chemical assay methodology and the analyzer's processing capabilities. The correlation values (e.g., Y = 0.95x + 1.90 with r² = 0.9943 for Cholesterol CP) demonstrate the agreement of the new device's measurements with those obtained by a "predicate device" or reference method, indicating its standalone analytical effectiveness.
7. Type of Ground Truth Used
The ground truth used for the correlation studies was likely the results obtained from the predicate devices against which the new HORIBA ABX PENTRA assays were compared. For example, for ABX PENTRA Cholesterol CP, the predicate device was K941573. The correlation equations (e.g., Y = 0.95x + 1.90) describe the relationship between the results of the new device (Y) and the predicate device (X).
8. Sample Size for the Training Set
This information is not provided in the document. For in vitro diagnostic devices, "training set" is generally not applicable in the same way as for AI/machine learning models. The development and optimization of the chemical reagents and assay parameters would involve internal R&D, but specific "training set" sizes are not typically reported in 510(k) summaries for such devices.
9. How Ground Truth for the Training Set Was Established
This information is not provided and is largely not applicable in the context of this type of device. The ground truth for developing and optimizing chemical assays would involve established analytical chemistry principles, reference materials, validation experiments, and comparisons with existing gold-standard or well-characterized methods, rather than an explicitly defined "ground truth for a training set" as seen in AI/ML development.
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