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510(k) Data Aggregation
(144 days)
The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes. ABX PENTRA Glucose HK CP, Glucose PAP CP reagents with associated calibrators and controls are for quantitative in vitro determination of glucose in serum and plasma using glucose hexokinase and glucose oxidase methods by colorimetry. Glucose measurements are used in diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The option of an I.S.E. (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Chloride, and Potassium by potentiometry using ion selective electrode with associated calibrators and controls. Measurement of these elements are used in diagnosis and treatment diseases involving electrolyte imbalance.
The ABX PENTRA 400 is a benchtop clinical chemistry analyzer using two measuring principals absorbance and ion selective electrodes. The instrument may be summarized as follows: Multi-parametric (up to 52 simultaneous tests + 3 ISE tests), Patient per patient, On routine or Stat, 150 to 300 tests / hour (in single or bi-reaction mode) (analytical cycle of 12seconds), random access working on primary tubes or sample cups, ABX PENTRA reagent cassettes are compact and ready-to-use, Automatic readers are used to identify newly loaded reagent cassettes and samples for patient identification. The ABX PENTRA 400 offers both Closed and Open channels for a multitude of applications (clinical chemistry, TDM, plasma protein, hemostasis, optional ISE module).
The provided text describes the ABX PENTRA 400 Clinical Chemistry Analyzer and various associated components. The study focuses on demonstrating substantial equivalence to predicate devices, rather than establishing primary performance criteria for an AI device. Therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness, standalone performance, ground truth for training set) are not applicable or cannot be extracted from this type of regulatory submission for a clinical chemistry analyzer.
However, I can provide the acceptance criteria and reported device performance for the analytes tested, as well as some information about the study design that can be inferred.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides performance data for several analytes (Glucose HK CP, Glucose PAP CP, Chloride-E, Potassium-E, Sodium-E). The "acceptance criteria" are implicitly met by the reported performance figures demonstrating substantial equivalence to predicate devices. For a clinical chemistry analyzer, key performance indicators include accuracy, precision (measured as CV Total), linearity/measuring range, and correlation with existing methods.
| Analyte (reagent/electrode) | Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|---|
| ABX PENTRA Glucose HK CP | Detection limit | Not explicitly stated, but within acceptable clinical range | 1.98 mg/dl |
| Accuracy and Precision | CV Total within acceptable limits | CV Total < 2.03% | |
| Measuring range | Clinically relevant range | 1.98 mg/dl – 900 mg/dl (Automatic post-dilution: 2700 mg/dl) | |
| Correlation (n=103) | High correlation (r²) to predicate/reference method | Y = 0.93 x + 2.70 with r² = 0.9958 | |
| Calibration stability | Clinically acceptable duration | 14 days | |
| Reagent stability | Clinically acceptable duration | on-board: 55 days | |
| ABX PENTRA Glucose PAP CP | Detection limit | Not explicitly stated, but within acceptable clinical range | 1.80 mg/dl |
| Accuracy and Precision | CV Total within acceptable limits | CV Total < 1.44 % | |
| Measuring range | Clinically relevant range | 1.80 mg/dl - 432 mg/dl (Automatic post-dilution: 1296 mg/dl) | |
| Correlation (n=103) | High correlation (r²) to predicate/reference method | Y = 0.98 x + 0.72 with r² = 0.9974 | |
| Calibration stability | Clinically acceptable duration | 11 days | |
| Reagent stability | Clinically acceptable duration | on-board: 83 days | |
| ABX PENTRA Chloride-E | Accuracy and Precision | CV Total within acceptable limits | CV Total < 1.21 % |
| Linearity & Measuring range | Clinically relevant range | Plasma/Serum: 85 - 200 mmol/l; Urine: 70 - 300 mmol/l | |
| Correlation (n=152 Serum/Plasma, n=103 Urine) | High correlation (r²) to predicate/reference method | Serum/Plasma: Y = 1.09 x - 10.60 with r² = 0.9651; Urine: Y = 0.99 x + 2.64 with r² = 0.9730 | |
| ABX PENTRA Potassium-E | Accuracy and Precision | CV Total within acceptable limits | CV Total < 1.56 % |
| Linearity & Measuring range | Clinically relevant range | Plasma/Serum: 1.4 - 10 mmol/l; Urine: 2 - 150 mmol/l | |
| Correlation (n=100 Serum, n=100 Plasma, n=103 Urine) | High correlation (r²) to predicate/reference method | Serum: Y = 1.00 x + 0.00 with r² = 0.9988; Plasma: Y = 1.00 x + 0.00 with r² = 0.9977; Urine: Y = 1.03 x - 0.72 with r² = 0.9753 | |
| ABX PENTRA Sodium – E | Accuracy and Precision | CV Total within acceptable limits | CV Total < 0.92 % |
| Linearity & Measuring range | Clinically relevant range | Plasma/Serum: 110 – 200 mmol/l; Urine: 80 – 300 mmol/l | |
| Correlation (n=100 Serum, n=100 Plasma, n=103 Urine) | High correlation (r²) to predicate/reference method | Serum: Y = 0.98 x + 2.64 with r² = 0.9991; Plasma: Y = 0.97 x + 4.77 with r² = 0.9960; Urine: Y = 1.00 x + 1.00 with r² = 0.9851 |
2. Sample sizes used for the test set and the data provenance:
- Glucose HK CP & Glucose PAP CP: n=103 for correlation studies (presumably patient samples). The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but given Horiba ABX is based in France, the studies were likely conducted in France or Europe.
- Chloride-E: n=152 for Serum/Plasma correlation, n=103 for Urine correlation.
- Potassium-E: n=100 for Serum correlation, n=100 for Plasma correlation, n=103 for Urine correlation.
- Sodium-E: n=100 for Serum correlation, n=100 for Plasma correlation, n=103 for Urine correlation.
- Data Provenance: Not explicitly stated, but given the company location, likely European/French data. The studies are clinical performance studies conducted to demonstrate equivalence, which typically involves prospective collection of samples or retrospective use of stored clinical samples. The document refers to "Clinical testing" which implies prospective data collection, but it's not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable for a clinical chemistry analyzer. "Ground truth" for these devices typically refers to established reference methods or predicate device measurements, not expert human interpretation.
4. Adjudication method for the test set:
Not applicable. As described above, this is not an interpretive AI device; it's a device measuring chemical analytes.
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:
Not applicable. This is not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the studies presented are "standalone" performance studies for the clinical chemistry analyzer and its components. The device measures analytes automatically; there is no human-in-the-loop performance analysis in this context beyond the technician operating the instrument and interpreting the numerical results. The performance metrics (accuracy, precision, linearity, correlation) represent the device's intrinsic function.
7. The type of ground truth used:
The "ground truth" in these studies is the measurement obtained from:
- Predicate devices: The performance data is presented in correlation studies, comparing the ABX PENTRA 400 (and its reagents/electrodes) results (Y) against another method (X), likely the predicate device or a recognized reference method. For example, "Correlation ... Y = 0.93 x + 2.70 with a correlation coefficient r² = 0.9958" implies a comparison against another method (x).
- Reference materials/known concentrations: Accuracy, precision, detection limit, linearity, and measuring range are typically established using reference materials with known concentrations and repeated measurements.
8. The sample size for the training set:
Not applicable. This device is a traditional clinical chemistry analyzer, not an AI/machine learning model that requires a distinct "training set." Its calibration involves specific calibrator solutions (e.g., ABX Pentra Multical, Standard 1, Standard 2, Reference), not a "training set" in the AI sense.
9. How the ground truth for the training set was established:
Not applicable, as there isn't a "training set" in the AI sense for this type of device. The calibration and performance verification are based on established laboratory practices, using commercially available calibrators and controls that have their own defined values.
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