Search Results
Found 1 results
510(k) Data Aggregation
(176 days)
General Chemistries reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.
ABX PENTRA ALP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
ABX PENTRA Calcium CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of calcium in human serum and plasma 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 CO2 RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of carbon dioxide in human serum and plasma based on an enzymatic test using phosphoenolpyruvate (PEP), phosphorenolpyruvate carboxylase (PEPC) and an analog of NADH. Bicarbonate/carbon measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
ABX PENTRA Creatinine CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of creatinine in human serum and plasma 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 Iron CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of iron (non-heme) in human serum and plasma based on a photometric test (Ferene method). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and hemochromatosis.
ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of phosphorus in human serum and plasma based on a UV method using phosphomolybdate. Measurement 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 Urea CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of urea nitrogen (an end-product of nitrogen metabolism) in human serum and plasma based on an enzymatic UV test using urease and glutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of uric acid in human serum and plasma based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
The ABX PENTRA CO2 Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CO2 RTU method on Horiba ABX clinical chemistry analyzers as specified on the vial.
The ABX PENTRA CO₂ Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CO2 RTU method as specified in the enclosed annex.
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 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).
All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters
Here's a breakdown of the acceptance criteria and study information for the Horiba ABX PENTRA reagents, controls, and calibrators, based on the provided 510(k) summary:
This submission is for multiple reagents, controls, and calibrators for the ABX PENTRA 400 clinical chemistry analyzer. The performance data is presented for each reagent individually. The acceptance criteria and reported performance will be summarized for each reagent as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the reported performance, which demonstrates that the devices "met all acceptance criteria" and are "substantially equivalent" to their respective predicate devices. Specific quantitative acceptance criteria are not explicitly stated as separate targets but are shown by the achieved performance values.
ABX PENTRA ALP CP (Alkaline phosphatase)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection limit met | 6 U/l |
| Accuracy and Precision met | CV Total < 4.36% |
| Measuring range met | 6 U/l – 1500 U/l (Automatic post-dilution: 6000 U/l) |
| Correlation met | Y = 1.07 x - 3.93 with r² = 0.998 |
| Calibration stability met | 7 hours |
| Reagent stability met | closed: 18 months at 2-8°C, on-board: 29 days |
ABX PENTRA Calcium CP (Calcium)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection limit met | 0.16 mg/dl |
| Accuracy and Precision met | CV Total < 1.67% |
| Measuring range met | 0.16 mg/dl – 20.1 mg/dl (Automatic post-dilution: 40.2 mg/dl) |
| Correlation met | Y = 1.15 x - 1.12 with r² = 0.950 |
| Calibration stability met | 6 hours |
| Reagent stability met | closed: 24 months at 2-8°C, on-board: 14 days |
ABX PENTRA CO2 RTU (Carbon Dioxide)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection limit met | 1.8 mmol/l |
| Accuracy and Precision met | CV Total < 7.7% |
| Measuring range met | 1.8 mmol/l - 60.8 mmol/l (Automatic post-dilution: 121.6 mmol/l) |
| Correlation met | Y = 0.85 x + 0.3 with r² = 0.976 |
| Calibration stability met | 1 day |
| Reagent stability met | closed: 16 months at 2-8°C, on-board: 28 days |
ABX PENTRA Creatinine CP (Creatinine)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection limit met | 0.11 mg/dl |
| Accuracy and Precision met | CV Total < 3.69% |
| Measuring range met | 0.11 mg/dl - 15.8 mg/dl (Automatic post-dilution: 79 mg/dl) |
| Correlation met | Y = 0.96 x - 0.12 with r² = 0.996 |
| Calibration stability met | 1 day |
| Reagent stability met | closed: 36 months at 2-8°C, on-board: 7 days |
ABX PENTRA Iron CP (Iron)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection limit met | 7.42 µg/dl |
| Accuracy and Precision met | CV Total < 3.61% |
| Measuring range met | 7.42 µg/dl – 1004 µg/dl (Automatic post-dilution: 5020 µg/dl) |
| Correlation met | Y = 1.13 x + 5.30 with r² = 0.997 |
| Calibration stability met | 8 days |
| Reagent stability met | closed: 24 months at 2-8°C, on-board: 41 days |
ABX PENTRA Magnesium RTU (Magnesium)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection limit met | 0.17 mg/dl |
| Accuracy and Precision met | CV Total < 3.19% |
| Measuring range met | 0.17 mg/dl - 4.64 mg/dl (Automatic post-dilution: 13.92 mg/dl) |
| Correlation met | Y = 1.23 x - 0.24 with r² = 0.971 |
| Calibration stability met | 2 days |
| Reagent stability met | closed: 24 months at 2-8°C, on-board: 7 days |
ABX PENTRA Phosphorus CP (Phosphorus)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection limit met | 0.28 mg/dl |
| Accuracy and Precision met | CV Total < 3.56% |
| Measuring range met | 0.28 mg/dl – 24.18 mg/dl (Automatic post-dilution: 96.72 mg/dl) |
| Correlation met | Y = 1.04 x + 0.19 with r² = 0.997 |
| Calibration stability met | 34 days |
| Reagent stability met | closed: 36 months at 2-8°C, on-board: 34 days |
ABX PENTRA Urea CP (Urea)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection limit met | Urea: 1.86 mg/dl, BUN: 0.9 mg/dl |
| Accuracy and Precision met | CV Total < 2.76% |
| Measuring range met | Urea: 1.86 - 300 mg/dl (Auto post-dilution: 1500 mg/dl); BUN: 0.9 - 140.3 mg/dl (Auto post-dilution: 701.5 mg/dl) |
| Correlation met | Urea: Y = 1.01 x + 1.80 with r² = 0.9905; BUN: Y = 1.01 x + 0.81 with r² = 0.9905 |
| Calibration stability met | 8 days |
| Reagent stability met | closed: 24 months at 2-8°C, on-board: 70 days |
ABX PENTRA Uric Acid CP (Uric Acid)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection limit met | 0.19 mg/dl |
| Accuracy and Precision met | CV Total < 2.81% |
| Measuring range met | 0.19 mg/dl - 25 mg/dl (Automatic post-dilution: 75 mg/dl) |
| Correlation met | Y = 0.97 x - 0.13 with r² = 0.958 |
| Calibration stability met | 15 days |
| Reagent stability met | closed: 36 months at 2-8°C, on-board: 41 days |
Controls and Calibrators Stability
| Product | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| ABX PENTRA CO2 Cal | Stability met | closed: 15 months at 2-25°C, open: 3 months at 2-25°C |
| ABX PENTRA Multical | Stability met | closed: 24 months at 2-8°C, open: 8 hours at 15-25°C, 2 days at 2-8°C, 2 weeks at -25-(-15)°C (with exceptions for Bilirubins) |
| ABX PENTRA CO2 Control | Stability met | closed: 15 months at 2-25°C, open: 3 months at 2-25°C |
| ABX PENTRA N Control | Stability met | closed: 30 months at 2-8°C, open: 12 hours at 15-25°C, 5 days at 2-8°C, 1 month at -25-(-15)°C (with exceptions for Bilirubins) |
| ABX PENTRA P Control | Stability met | closed: 30 months at 2-8°C, open: 12 hours at 15-25°C, 5 days at 2-8°C, 1 month at -25-(-15)°C (with exceptions for Bilirubins) |
2. Sample Sizes Used for the Test Set and Data Provenance
The sample sizes for the correlation studies (which serve as the primary test set for comparing to predicate devices) are as follows:
- ABX PENTRA ALP CP: n=105
- ABX PENTRA Calcium CP: n=95
- ABX PENTRA CO2 RTU: n=97
- ABX PENTRA Creatinine CP: n=95
- ABX PENTRA Iron CP: n=98
- ABX PENTRA Magnesium RTU: n=75
- ABX PENTRA Phosphorus CP: n=105
- ABX PENTRA Urea CP: n=108
- ABX PENTRA Uric Acid CP: n=98
The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the provided summary. However, the company is based in France and the submission is for the US market. The samples are described generally as "human serum and plasma".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as the devices are in vitro diagnostic reagents for quantitative measurement, not diagnostic imaging devices requiring expert interpretation for ground truth. The "ground truth" for correlation studies would typically be the results obtained from a legally marketed predicate device or a reference method.
4. Adjudication Method for the Test Set
This is not applicable for this type of in vitro diagnostic device study. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments.
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 is not applicable as the devices are in vitro diagnostic reagents and not AI-powered diagnostic tools for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The entire performance data presented is for the standalone (algorithm only) performance of the reagents when used with the ABX PENTRA 400 analyzer. There is no human-in-the-loop component for these quantitative chemistry measurements.
7. The type of ground truth used
The "ground truth" for the performance studies, particularly the correlation data, is implicitly established by comparison to results from legally marketed predicate devices or established reference methods. This is indicated by the statement of "substantial equivalence" to named predicate devices and the correlation data that compares the results of the new device (Y) to an existing method (x).
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. For in vitro diagnostic devices like these, method development and optimization would precede the validation studies, but a distinct "training set" as understood in AI is not typically a component of the regulatory submission for this type of product. The performance data presented are for the validation of the finalized method.
9. How the Ground Truth for the Training Set Was Established
Given that a "training set" in the AI sense is not explicitly mentioned or applicable for these devices, the question of how its ground truth was established is not applicable. The development of the reagents involves standard chemical and analytical validation processes to ensure accuracy and precision, typically against reference standards and established methods, often during an internal R&D phase.
Ask a specific question about this device
Page 1 of 1