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510(k) Data Aggregation
(204 days)
ABX PENTRA Enzymatic Creatinine CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on an enzymatic method using a multi-step approach ending with a photometric end-point reaction. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
All the reagent, controls and calibrator included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA Enzymatic Creatinine CP is an in vitro diagnostic assay for the quantitative in vitro determination of creatinine in human serum, plasma and urine based on an enzymatic method using a multi-step approach ending with a photometric end-point reaction. It is composed of a bi-reagent cassette (R1= 22 mL ; R2= 8 mL). Reagent is a chemical solution with additives.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexe, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
The provided text describes performance data for the ABX PENTRA Enzymatic Creatinine CP reagent, along with associated calibrators and controls, for use on the ABX PENTRA 400 clinical chemistry analyzer. The study aims to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents performance data for the ABX PENTRA Enzymatic Creatinine CP reagent, which implicitly serve as acceptance criteria for its clearance.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Detection Limit | Not explicitly stated as acceptance criteria, but reported values are key performance indicators. | Serum/Plasma: 0.026 mg/dlUrine: 0.66 mg/dl |
| Limit of Quantitation | Not explicitly stated as acceptance criteria, but reported values are key performance indicators. | Serum/Plasma: 0.11 mg/dlUrine: 1.71 mg/dl |
| Accuracy and Precision | Total CV for Serum/Plasma < 4.12%Total CV for Urine < 4.84% | Serum/Plasma CV Total < 4.12%Urine CV Total < 4.84% |
| Measuring Range | Not explicitly stated as acceptance criteria, but reported values are key performance indicators. | Serum/Plasma: 0.11 mg/dl - 16.95 mg/dlUrine: 3.56 mg/dl - 175 mg/dl |
| Upper Linearity Limit | Not explicitly stated as acceptance criteria, but reported values are key performance indicators. | Serum/Plasma: 16.95 mg/dl (50.85 mg/dl with auto post-dilution)Urine: 175 mg/dl (525 mg/dl with auto post-dilution) |
| Correlation | High correlation (r²) close to 1 with predicate (or reference) method. | Serum/Plasma (n=153): Y = 1.00 x + 0.00 (mg/dl) with r² = 0.999.Urine (n=105): Y = 0.97 x - 0.33 (mg/dl) with r² = 0.9982. |
| Calibration Stability | Serum/Plasma: 14 daysUrine: 14 days | Serum/Plasma: 14 daysUrine: 14 days |
| Reagent Stability | Closed: 18 months at 2-8°COn-board: 30 days | Closed: 18 months at 2-8°COn-board: 30 days |
For the calibrators (ABX PENTRA Multical) and controls (ABX PENTRA N Control, ABX PENTRA P Control, ABX PENTRA Urine Control L/H), the acceptance criteria relate to their stability (closed and open vial) and their ability to ensure optimal calibration and control of the methods. The document reports specific stability periods for each.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For Correlation testing (Creatinine CP reagent):
- Serum/Plasma: n=153
- Urine: n=105
- The sample sizes for other performance metrics (detection limit, limit of quantitation, accuracy, precision, measuring range, linearity, stability) are not explicitly stated in the provided text. They are summarized, but the number of unique samples used to establish these values is not detailed.
- For Correlation testing (Creatinine CP reagent):
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable to this type of device and study. The device is a clinical chemistry reagent for quantitative determination, not a diagnostic imaging or AI device requiring expert interpretation for ground truth establishment. The ground truth here would be established by a reference method (the predicate device K070383 for Creatinine) or a recognized laboratory standard.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., radiologists interpreting images) to resolve discrepancies and establish a consensus ground truth. For a quantitative chemical assay, the comparison is against an established reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable to this type of device and study. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic interpretation, which is not the function of a clinical chemistry reagent.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an algorithm in the AI sense. This device is a reagent system that performs quantitative chemical analysis. The performance data presented (accuracy, precision, correlation, etc.) is the standalone performance of the reagent system on the analyzer, without human interpretation as a performance metric.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the Creatinine CP reagent, the ground truth for performance evaluation (specifically correlation) would have been established by comparing the results obtained using the new device against results from a legally marketed predicate device (K070383) or a recognized reference method. The "Y = 1.00 x + 0.00 (mg/dl)" correlation equations suggest a comparison against a reference method, where 'x' represents the reference method's result.
For the calibrators and controls, the "assigned values" for their components are the ground truth, ensuring optimal calibration and control. These values are established through rigorous testing and standardization, often traceable to international reference materials.
8. The Sample Size for the Training Set
This information is not explicitly provided in the summary. For a medical device like a chemical reagent, the "training set" concept is not directly analogous to machine learning. However, the development and optimization of the reagent formulation and methods would involve extensive internal testing using numerous samples to establish the assay's characteristics before formal validation studies. The provided summary focuses on the validation data.
9. How the Ground Truth for the Training Set Was Established
As mentioned in point 8, the concept of a "training set" and its "ground truth" establishment isn't directly applicable in the same way as AI/ML devices. For a chemical reagent, the development process would involve:
- Reference Methods: Using established, highly accurate reference methods or certified reference materials to determine the true values of analytes in samples used during development.
- Standardization: Developing and refining the assay chemistry to consistently achieve accurate and precise measurements against these reference values.
- Specifications: Establishing performance specifications based on clinical requirements and comparison to existing, cleared methods.
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