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510(k) Data Aggregation
(90 days)
ABX PENTRA Calcium CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
ABX PENTRA Creatinine CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic 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 Phosphorus CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
ABX PENTRA Amylase CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum, plasma and urine 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 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 Calcium CP is an in vitro diagnostic assay for the quantitative determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. It is composed of a bi-reagent cassette, with 66 ml and 16.5 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Creatinine 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 bi-reagent cassette, with two 28 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Phosphorus CP is an in vitro diagnostic assay for the quantitative determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. It is composed of a mono-reagent cassette, with 29.5 ml compartment. The reagent is a chemical solution with additives.
The ABX PENTRA Amylase CP is an in vitro diagnostic assay for the quantitative determination of alpha-amylase in human serum, plasma and urine 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 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 methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
The provided text describes the performance data for new urine sample indications for four reagents (ABX PENTRA Calcium CP, ABX PENTRA Creatinine CP, ABX PENTRA Phosphorus CP, and ABX PENTRA Amylase CP) when used with the ABX PENTRA 400 Clinical Chemistry Analyzer. The study aims to demonstrate substantial equivalence to predicate devices and establish performance characteristics for urine samples.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are implied by the reported performance characteristics for each reagent on urine samples. While explicit "acceptance criteria" are not listed as pass/fail thresholds, the reported values represent the achieved performance that allowed for the 510(k) clearance.
ABX PENTRA Calcium CP (Urine)
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sample type | Urine | Urine |
| Detection limit | Not explicitly defined | 0.12 mg/dl |
| Accuracy and Precision | Not explicitly defined | CV Total < 3.61% |
| Measuring range | Not explicitly defined | 0.12 mg/dl – 24.06 mg/dl |
| Upper linearity limit | Not explicitly defined | 24.06 mg/dl (48.12 mg/dl with auto-dilution) |
| Correlation (n=124) | Not explicitly defined | Y = 1.13 x - 0.50, r² = 0.9904 |
| Calibration stability | Not explicitly defined | 6 hours |
| Reagent stability (closed) | Not explicitly defined | 24 months at 2-8°C |
| Reagent stability (on-board) | Not explicitly defined | 14 days |
ABX PENTRA Creatinine CP (Urine)
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sample type | Urine | Urine |
| Detection limit | Not explicitly defined | 1.3 mg/dl |
| Accuracy and Precision | Not explicitly defined | CV Total < 4.60% |
| Measuring range | Not explicitly defined | 1.3 mg/dl - 316.4 mg/dl |
| Upper linearity limit | Not explicitly defined | 316.4 mg/dl (949.2 mg/dl with auto-dilution) |
| Correlation (n=110) | Not explicitly defined | Y = 0.99 x - 0.98, r² = 0.9953 |
| Calibration stability | Not explicitly defined | 1 day |
| Reagent stability (closed) | Not explicitly defined | 36 months at 2-8°C |
| Reagent stability (on-board) | Not explicitly defined | 7 days |
ABX PENTRA Phosphorus CP (Urine)
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sample type | Urine | Urine |
| Detection limit | Not explicitly defined | 1.28 mg/dl |
| Accuracy and Precision | Not explicitly defined | CV Total < 5.95% |
| Measuring range | Not explicitly defined | 1.28 mg/dl - 198.4 mg/dl |
| Upper linearity limit | Not explicitly defined | 198.4 mg/dl (396.8 mg/dl with auto-dilution) |
| Correlation (n=119) | Not explicitly defined | Y = 1.07 x - 1.10, r² = 0.9892 |
| Calibration stability | Not explicitly defined | 34 days |
| Reagent stability (closed) | Not explicitly defined | 36 months at 2-8°C |
| Reagent stability (on-board) | Not explicitly defined | 34 days |
ABX PENTRA Amylase CP (Urine)
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sample type | Urine | Urine |
| Detection limit | Not explicitly defined | 4.92 U/l |
| Accuracy and Precision | Not explicitly defined | CV Total < 6.03% |
| Measuring range | Not explicitly defined | 4.92 U/l – 2000 U/l |
| Upper linearity limit | Not explicitly defined | 2000 U/l (6000 U/l with auto-dilution) |
| Correlation (n=121) | Not explicitly defined | Y = 1.17 x + 21.90, r² = 0.9891 |
| Calibration stability | Not explicitly defined | 8 days |
| Reagent stability (closed) | Not explicitly defined | 24 months at 2-8°C |
| Reagent stability (on-board) | Not explicitly defined | 42 days |
Study Details
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Sample sizes used for the test set and the data provenance:
- ABX PENTRA Calcium CP: n=124 for correlation studies.
- ABX PENTRA Creatinine CP: n=110 for correlation studies.
- ABX PENTRA Phosphorus CP: n=119 for correlation studies.
- ABX PENTRA Amylase CP: n=121 for correlation studies.
The text does not specify the country of origin of the data or whether the data was retrospective or prospective. Given the company is based in France, it's possible the studies were conducted there. The context of a 510(k) submission generally implies prospective studies or well-controlled retrospective studies for performance validation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The text does not provide information on the number or qualifications of experts used to establish ground truth. -
Adjudication method for the test set:
The text does not specify any adjudication method. For chemical assays, ground truth is typically established by comparative methods (predicate device or accepted reference method), not expert adjudication. -
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. The device described consists of chemical reagents and controls for a clinical chemistry analyzer, not an AI or imaging device with "human readers." -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a chemical reagent and not an algorithm. The reported performance characteristics (detection limit, accuracy, precision, measuring range, linearity, correlation, stability) are a standalone performance of the reagent on the ABX PENTRA 400 analyzer. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the correlation studies, the ground truth was established by comparison (correlation) with another method (presumably the predicate device or a recognized reference method), as indicated by the "Y = mx + b" equations and correlation coefficients (r²). The text states: "Correlation (n=XXX) Y = (value) with a correlation coefficient r² = (value)." This implies a comparison against a reference method. -
The sample size for the training set:
The text does not provide information about a "training set." For these types of diagnostic assays, methods are developed and optimized through R&D, and then validated with test sets. The concept of a distinct "training set" as used in machine learning is generally not directly applicable. -
How the ground truth for the training set was established:
Not applicable, as a "training set" in the machine learning sense is not mentioned or implied for these chemical assays.
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