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ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro 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.

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical 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.

The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

All the reagent, controls and calibrator 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 Creatinine 120 CP is an in vitro diagnostic assay for the quantitative in vitro 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 (R1= 27.5 mL ; R2= 8 mL). 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 assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS 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 SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.

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 annex, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.

The provided text describes the acceptance criteria and performance data for the ABX PENTRA Creatinine 120 CP reagent and associated calibrators/controls, for use on the ABX PENTRA 400 clinical chemistry analyzer.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices." However, the exact numerical acceptance criteria values themselves (e.g., maximum allowable CV, minimum r2) for each parameter are not explicitly defined in the provided text, but are implied by the reported performance falling within acceptable ranges for substantial equivalence to the predicate devices.

2. Sample sizes used for the test set and the data provenance

• Creatinine 120 CP (Test Set):
  • Serum/Plasma Correlation: n = 165
  • Urine Correlation: n = 117
• Data Provenance: Not explicitly stated, but the company is Horiba ABX SAS, FRANCE, suggesting the data may originate from France or related study sites. The study is for premarket notification, implying prospective testing for device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided in the text. For in vitro diagnostic devices like this, ground truth is typically established by comparing performance to an established, often predicate, method or reference method, rather than through expert consensus in the way a medical imaging AI might use radiologists.

4. Adjudication method for the test set

• This information is not provided as it's not relevant for this type of in vitro diagnostic device performance study. Performance is assessed quantitatively against a reference method or specified analytical limits.

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 information is not applicable/not provided. This is an in-vitro diagnostic assay and associated controls/calibrators, not an AI-assisted diagnostic tool that involves human readers interpreting results.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This is a standalone diagnostic assay (reagent, calibrator, control) for use on an automated clinical chemistry analyzer (ABX PENTRA 400). The performance data presented (detection limits, accuracy, precision, measuring range, correlation, stability) reflect the standalone analytical performance of the device on the analyzer. There is no "human-in-the-loop" component for the measurement process itself beyond loading samples and reagents.

7. The type of ground truth used

• For the ABX PENTRA Creatinine 120 CP reagent, the ground truth for correlation studies was established by comparing its measurements (Y) against those of the predicate device/method (X), as indicated by the correlation equations (e.g., "Y = 0.99 x + 0.03"). This implies a comparative method ground truth (i.e., comparison against a legally marketed, established method).
• For the calibrators and controls, the "assigned values" of their components serve as their reference values or ground truth, established through rigorous manufacturing and value assignment processes.

8. The sample size for the training set

• This information is not provided. This type of in vitro diagnostic device is chemically based and does not typically involve a "training set" in the machine learning sense. The development likely involves extensive R&D and analytical validation, but not a distinct "training set" of patient data for a learning algorithm.

9. How the ground truth for the training set was established

• This information is not applicable as there is no "training set" in the context of this device's development as described.

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Creatinine and Total Protein 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 Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro 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 Total Protein 100 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.

Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

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.

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 Creatinine 120 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 27 ml monoreagent cassette. Reagent is a chemical solution with additives.

The ABX PENTRA Total Protein 100 CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 28 ml mono-reagent cassette. Reagent is a chemical solution 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 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.

Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA Creatinine 120 CP and ABX PENTRA Total Protein 100 CP devices, based on the provided text:

Acceptance Criteria and Device Performance

The devices are in vitro diagnostic assays, and their performance is described in terms of analytical characteristics. The stated performance data implicitly serve as the acceptance criteria for the devices to be considered substantially equivalent to their predicate devices.

ABX PENTRA Creatinine 120 CP

ABX PENTRA Total Protein 100 CP

Study Information

The document describes the performance data for in vitro diagnostic reagents. The studies performed are analytical performance studies, not clinical studies involving human patients or ground truth established by medical experts for diagnostic interpretation.

1. Sample size used for the test set and the data provenance:

   • ABX PENTRA Creatinine 120 CP:
     • Serum/Plasma correlation study: n=122 samples.
     • Urine correlation study: n=119 samples.
   • ABX PENTRA Total Protein 100 CP:
     • Correlation study: n=178 samples.
   • Data Provenance: The document states "HORIBA ABX, FRANCE" as the company location, implying the studies were conducted or samples sourced from France. The data is retrospective in the sense that it's laboratory performance data generated to characterize the assay, not new prospective patient data collected for a clinical trial.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. For in vitro diagnostic reagents, "ground truth" is typically established by reference methods or validated comparative assays. The correlation studies are comparing the performance of the new device against a comparative method. The text does not specify the comparative method used, nor does it mention any human experts establishing ground truth for these analytical measurements.

3. Adjudication method for the test set:

   • Not applicable. Analytical studies for these types of reagents do not typically involve human adjudication of results. The "truth" or reference values for the samples would be determined by the comparative method.

4. 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. These are in vitro diagnostic reagents that measure chemical analytes. They are not AI-powered image analysis devices or clinical decision support tools that would involve human readers or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, these are standalone analytical performance studies of reagents and their performance on an automated analyzer (ABX PENTRA 400). The "algorithm" here refers to the chemical reaction and measurement process of the diagnostic assay itself. Human intervention is limited to sample loading, instrument operation, and quality control, but the measurement itself is automated.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for these analytical performance studies is implicitly the results obtained from a comparative method or reference method against which the new device's measurements are correlated. The document states "Correlation" with r² values, indicating a comparison against another measurement method. The nature of this comparative method (e.g., another FDA-cleared creatinine assay) is not explicitly detailed but is standard practice for IVD submissions.

7. The sample size for the training set:

   • Not applicable. These are chemical reagents following established principles (Jaffé method, Biuret reaction). They are not machine learning or AI-based algorithms that require "training sets" in the conventional sense. The development of such reagents involves extensive research and development, but not "training data" in the AI context.

8. How the ground truth for the training set was established:

   • Not applicable (as explained above).

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