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510(k) Data Aggregation
(272 days)
Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.
ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test.
Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy.
The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods.
ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoqlobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay.
Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision.
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 CK NAC CP is an in vitro diagnostic assay for the quantitative determination of total creatine kinase in human serum and plasma based on an optimized UV 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 Myoglobin CP is an in vitro diagnostic assay for the quantitative determination of myoglobin in human serum and plasma based on a latex-enhanced immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 15 ml and 9.5 ml compartments. Reagents are chemical solutions with chemical additives and substances of animal origin.
The ABX PENTRA Myoglobin Cal is a liquid calibrator prepared from a dilution of purified myoglobin positive human sera. It is used for the calibration of the myoglobin assay. The assigned values are given on the vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA CK Control is a lyophilized assayed control prepared from a bovine serum albumin with chemical additives and material of biological origin. It has to be used for the quality control of the creatine kinase assay. The assigned values are given in the enclosed annex. This calibrator is provided in 4 vials of 3 ml.
The ABX PENTRA Immuno II Control L/H is a lyophilized assayed control prepared from a stabilized pool of human sera. It has 2 levels (Low and High) to be used for the quality control of the myoglobin assay. The assigned values are given in the enclosed annex. Each level of this control is provided in one vial of 3 ml.
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 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 methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
This submission describes various reagents, controls, and calibrators for in vitro diagnostic use with the Horiba ABX Pentra 400 clinical chemistry analyzer. The performance data focuses on establishing substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily performance characteristics of the various reagents, controls, and calibrators.
ABX PENTRA CK NAC CP (Reagent for Total Creatine Kinase)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 8 U/l |
| Accuracy and Precision | CV Total < 4.65% |
| Measuring range | 8 U/l - 1500 U/l |
| Upper linearity limit | 1500 U/l, and with automatic post-dilution: 4500 U/l |
| Correlation (n=350) | Y = 1.05 x - 1.75 with a correlation coefficient r² = 0.9930 |
| Calibration stability | 8 days |
| Reagent stability (closed) | 18 months at 2-8°C |
| Reagent stability (on-board) | 64 days (refrigerated area) |
ABX PENTRA Myoglobin CP (Reagent for Myoglobin)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 6.7 µg/l |
| Accuracy and Precision | CV Total < 5.24% |
| Measuring range | 20.7 µg/l – 500 µg/l |
| Upper linearity limit | 500 µg/l |
| Correlation (n=180) | Y = 0.94 x + 19.44 with a correlation coefficient r² = 0.9756 |
| Calibration stability | 21 days |
| Reagent stability (closed) | 12 months at 2-8°C |
| Reagent stability (on-board) | 35 days (refrigerated area) |
ABX PENTRA Myoglobin Cal (Calibrator)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analytes | Myoglobin |
| Format | Liquid preparation of diluted purified myoglobin positive human sera: 5 levels |
| Stability (closed) | 12 months at 2°C to 10°C |
| Stability (open) | 7 weeks at 2°C to 10°C |
ABX PENTRA Multical (Calibrator)
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Analytes | Various, including Creatine kinase (included in this submission) |
| Format | Lyophilized human serum with chemical additives and materials of biological origin |
| Stability (closed) | 24 months at 2-8°C |
| Stability (open) | General components: 8 hours at 15-25°C, 2 days at 2-8°C, 2 weeks at -25- -15°C Direct Bilirubin: 3 hours at 15-25°C, 8 hours at 2-8°C, 2 weeks at -25- -15°C Total Bilirubin: 6 hours at 15-25°C, 1 day at 2-8°C, 2 weeks at -25- -15°C |
ABX PENTRA CK Control (Control)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analytes | Total Creatine Kinase |
| Format | Lyophilized preparation of bovine serum albumin with chemical additives and material of animal origin |
| Stability (closed) | 18 months at 2°C to 8°C |
| Stability (open) | 24 hours at 15°C to 25°C, 3 days at 2°C to 8°C |
ABX PENTRA Immuno II Control L/H (Control)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analytes | Myoglobin |
| Format | Lyophilized preparation of bovine serum albumin with chemical additives and material of animal origin |
| Stability (closed) | 18 months at 2°C to 10°C |
| Stability (open) | 2 weeks at 2°C to 10°C, 3 months at -20°C |
ABX PENTRA N Control and ABX PENTRA P Control (Controls)
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Analytes | Various, including Creatine kinase (N Control, P Control) |
| Format | Lyophilized human serum with chemical additives and materials of biological origin |
| Stability (closed) | 30 months at 2-8°C |
| Stability (open) | General components: 12 hours at 15-25°C, 5 days at 2-8°C, 1 month at -25- -15°C Direct Bilirubin: 4 hours at 15-25°C, 8 hours at 2-8°C, 2 weeks at -25- -15°C Total Bilirubin: 8 hours at 15-25°C, 1 day at 2-8°C, 2 weeks at -25- -15°C |
2. Sample Size Used for the Test Set and Data Provenance
- ABX PENTRA CK NAC CP: Correlation study used n=350 samples.
- ABX PENTRA Myoglobin CP: Correlation study used n=180 samples.
- Data Provenance: Not explicitly stated, but the submission is from Horiba ABX, France. Given the nature of in vitro diagnostic device submissions for a global market, it is common for such studies to be conducted internally or at contract research organizations, potentially in the country of origin (France) or other locations. The document does not specify if the data is retrospective or prospective, but performance data for new IVD products is typically generated prospectively, though some method comparison might involve retrospective samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As an in vitro diagnostic device for quantitative determination of analytes, "ground truth" is typically established by reference methods or predicate devices, not by expert interpretation of images or clinical cases. The "experts" in this context would be the laboratory personnel performing the reference method assays or clinical chemists validating the results. Their qualifications are not detailed in this submission.
4. Adjudication Method for the Test Set
Not applicable. This is for an in vitro diagnostic assay, not a medical imaging or diagnostic interpretation device requiring adjudication of expert opinions. Performance is assessed through quantitative measurements, precision, accuracy, linearity, and correlation with predicate devices.
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. It's a collection of reagents, controls, and calibrators for a chemistry analyzer.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
Not applicable for an IVD reagent/calibrator/control submission. The device performs a quantitative measurement on an automated analyzer. Its performance is inherently "standalone" in the sense that the analyzer and reagents perform the test without human interpretive input for the result itself. Human involvement is in sample handling, loading, running, and interpreting the numerical result in a clinical context.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the performance studies (accuracy, correlation), the "ground truth" is established by comparison to results obtained from predicate devices (as detailed in the substantial equivalence table) or established reference methods. For example, the correlation studies show the device's results (Y) compared to a reference method or predicate device's results (x). Precision and linearity are evaluated against expected analytical performance criteria.
8. The Sample Size for the Training Set
Not applicable. These are chemical reagents, controls, and calibrators for an in vitro diagnostic assay, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this type of device.
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