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510(k) Data Aggregation
(63 days)
Amylase reagent, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure amylase analyte.
ABX PENTRA Amylase CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum and plasma based on an enzymatic photometric assay. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
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 Amylase CP is an in vitro diagnostic assay for the quantitative determination of alpha-amylase in human serum and plasma based on an enzymatic photometric 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 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 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.
Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA Amylase CP and its associated calibrators and controls, based on the provided 510(k) summary:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| ABX PENTRA Amylase CP | ||
| Sample Type | N/A (indicates acceptable sample types) | Serum & plasma |
| Detection Limit | N/A | 4 U/l |
| Accuracy and Precision | CV Total < N/A (implied target for robust performance) | CV Total < 2.74% |
| Measuring Range | N/A | 4.5 U/l – 2042 U/l |
| Upper Linearity Limit | N/A | 2000 U/l, and with automatic post-dilution: 6000 U/l |
| Correlation (vs predicate) | High correlation coefficient (r² close to 1) | Y = 1.17 x - 6.23 with a correlation coefficient r² = 0.9971. (n=131) |
| Calibration Stability | N/A | 8 days |
| Reagent Stability (closed) | N/A | 24 months at 2-8°C |
| Reagent Stability (on-board) | N/A | 42 days (refrigerated area) |
| ABX PENTRA Multical | ||
| Stability (closed) | N/A | 24 months at 2-8°C |
| Stability (open) | N/A | 8 hours at 15°C to 25°C2 days at 2°C to 8°C2 weeks at -25°C to -15°C |
| ABX PENTRA N Control / P Control | ||
| Stability (closed) | N/A | 30 months at 2-8°C |
| Stability (open) | N/A | 12 hours at 15°C to 25°C5 days at 2°C to 8°C1 month at -25°C to -15°C |
| Overall Conclusion | Safety and effectiveness not compromised, met all acceptance criteria. | Performance testing data demonstrated substantial equivalence to predicate devices. |
Study Information:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive de novo clinical study report. Therefore, many of the detailed study elements typically found in a clinical trial are not explicitly documented here.
2. Sample size used for the test set and the data provenance
- Sample Size (for correlation): n=131 (for regression analysis of ABX PENTRA Amylase CP against the predicate).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This information is usually detailed in a full study report, not a summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is a clinical chemistry assay for quantitative enzyme determination, not an imaging device requiring expert interpretation for ground truth. The "ground truth" for correlation studies would typically be the results from the predicate device.
4. Adjudication method for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., imaging reads). For clinical chemistry, the "truth" is measured by the reference method (predicate device) and compared quantitatively.
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 device, nor does it involve human readers interpreting cases. It's a quantitative clinical chemistry assay.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance data presented (detection limit, accuracy/precision, measuring range, linearity, correlation, stability) are all "standalone" performance metrics of the device (reagent, calibrators, controls, and analyzer system) without human intervention in the result generation beyond operating the analyzer.
7. The type of ground truth used
- For the ABX PENTRA Amylase CP, the ground truth for the correlation study against the predicate would be the results obtained from the predicate device (K801295) for amylase measurement. The predicate device itself would have been validated against an established laboratory reference method or gold standard.
- For stability and other performance metrics, the "ground truth" would be the known concentration/activity of the analytes in control materials or the expected performance characteristics based on established analytical methods.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a distinct training set. The "training" of such a device involves optimizing the chemical reactions, instrument parameters, and calibration algorithms during development, which typically uses internal R&D data rather than a formal "training set" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as point 8.
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