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The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Uric acid measurements 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE CK Reagent is intended for the quantitative determination of creatine kinase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE BUN/Urea Reagent assay, urea in serum is hydrolyzed in the presence of urease to yield ammonia and carbon dioxide. The ammonia formed then reacts in the presence of glutamate dehydrogenase with 2-oxoglutarate and NADH to yield glutamate and NAD. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initial rate of decrease in absorbance, monitored bichromatically at 340 nm/647 nm, is proportional to the urea concentration in the sample.

In the ACE Creatinine Reagent assay, creatinine reacts with picric acid in an alkaline medium to form a red-orange colored complex, which absorbs strongly at 505 nm. The rate of complex formation, determined by measuring the increase in absorbance bichromatically at 505 nm/573 nm during a fixed time interval, is directly proportional to the creatinine concentration in the sample.

In the ACE Uric Acid Reagent assay, uric acid in serum is oxidized by uricase to allantoin and hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple dichlorohydroxybenzene sulfonic acid and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex, which absorbs strongly at 505 nm. The amount of chromogen formed is determined by measuring the increase in absorbance bichromatically at 505 nm/610 nm, and is directly proportional to the uric acid concentration in the sample.

In the ACE CK Reagent assay, serum creatine kinase initiates the conversion of creatine phosphate to creatine with the transfer of a phosphate group to adenosine diphosphate (ADP), forming ATP. The ATP is then used in the phosphorylation of D-glucose to form D-glucose-6-phosphate and ADP. This reaction is catalyzed by hexokinase. The enzyme glucose-6-phosphate dehydrogenase catalyzes the reduction of D-glucose-6-phosphate and nicotinamide adenine dinucleotide phosphate (NADP+). The series of reactions triggered by serum creatine kinase and ending in the formation of NADPH. NADPH strongly absorbs at 340 nm, whereas NADP+ does not. Therefore, the rate of conversion of NADP+ to NADPH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/378 nm. This rate of conversion from NADP+ to NADPH is a function of the activity of CK in the sample.

Here's a summary of the acceptance criteria and supporting studies for the Alfa Wassermann ACE Reagents (BUN/Urea, Creatinine, Uric Acid, CK), based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from comparisons to a predicate device (Alfa Wassermann ACE K930104 reagents) and performance characteristics such as precision, accuracy (correlation/regression with predicate), linearity, detection limits, and interference. The reported device performance is from in-house studies and Point-of-Care (POL) studies.

Note: The document does not explicitly state "acceptance criteria" numerical targets. Instead, it presents performance data for the candidate device, implying that the data's comparability to the predicate and established analytical standards is the basis for acceptance. I will present the reported performance, which demonstrates the device's meeting the necessary equivalency.

Studies Proving Acceptance Criteria:

The studies are described under "Performance Data" and "Device Comparison with Predicate" sections of the 510(k) summary. These studies aim to demonstrate substantial equivalence to the previously cleared predicate device (Alfa Wassermann ACE BUN/Urea Reagent, ACE Creatinine Reagent, ACE Uric Acid Reagent, and ACE CK Reagents, K930104).

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Matrix Comparison: Serum vs. Plasma):

  • BUN: 95 pairs (ACE), 96 pairs (Alera), 51 pairs (Axcel)
  • Creatinine: 102 pairs (ACE), 102 pairs (Alera), 55 pairs (Axcel)
  • Uric Acid: 97 pairs (ACE), 95 pairs (Alera), 55 pairs (Axcel)
  • CK: 94 pairs (ACE), 96 pairs (Alera), 55 pairs (Axcel)
  • Data Provenance: The document states "In-House Precision" and "In-House Matrix Comparison". This typically implies that the data was generated within the manufacturer's laboratory or a testing facility under their control. The country of origin is not explicitly stated but is implicitly the US, given the 510(k) submission to the FDA. The data is retrospective, as it's being used to characterize reagent performance.

• Test Set (POL - Method Comparison):

  • BUN: 53-54 samples per POL lab for comparison with In-House ACE.
  • Creatinine: 51 samples per POL lab for comparison with In-House ACE.
  • Uric Acid: 49 samples per POL lab for comparison with In-House ACE.
  • Creatinine Kinase: 48-50 samples per POL lab for comparison with In-House ACE.
  • Data Provenance: "POL - Method Comparison" indicates data from Physician Office Laboratories (POLs), likely external to the main testing facility but still considered part of the overall validation. The document refers to "In-House ACE (x) vs. POL 1 ACE (y)", "POL 2 ACE (y)", etc., indicating comparisons against internal reference methods. The data is retrospective.

• Test Set (Detection Limits, Linearity, Interferences, Alera Precision): The sample sizes for these specific studies are not explicitly detailed in the provided summary beyond "Low level tested," "Upper level tested," and "number of replicates for precision measurements (i.e. '3.2, 4.0%') implies multiple measurements. These are likely in-house, retrospective studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For in vitro diagnostic devices like these reagents, the "ground truth" is typically established by reference methods or validated comparative methods, often run on established clinical chemistry analyzers. The expertise lies in operating these reference instruments and ensuring proper laboratory practices, rather than expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are common in studies involving subjective interpretations (e.g., medical image analysis by radiologists) where discrepancies among readers need to be resolved to establish ground truth. For quantitative IVD reagents, the reference method provides a direct numerical result, not a subjective interpretation requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This is not applicable to this type of device. MRMC studies are used to assess the effectiveness of an AI system (or any diagnostic aid) for human readers, particularly in medical imaging. The current device is a diagnostic reagent, which directly measures chemical concentrations, not an AI intended to assist human interpretation of cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable in the context of an IVD reagent. The "algorithm" here is the chemical reaction and photometric measurement itself. The performance data presented (precision, linearity, method comparison, etc.) is the standalone performance of the reagent on the specified analyzers, without human interpretive input altering the result.

7. Type of Ground Truth Used

The ground truth for all performance studies (precision, matrix comparison, method comparison, linearity) is established by comparison against a reference method or a substantially equivalent predicate method performed on existing, validated clinical chemistry analyzers (specifically, the predicate ACE Clinical Chemistry System and the candidate ACE, ACE Alera, and ACE Axcel systems themselves acting as the "reference" for their own performance claims, and for method comparisons, the "In-House ACE" results). This is a common and accepted approach for demonstrating substantial equivalence for IVD reagents.

8. Sample Size for the Training Set

This information is not provided and is generally not applicable in the way it is asked for AI/ML devices. These are chemical reagents, not AI/ML algorithms that require "training sets" in the conventional sense of machine learning. The development process would involve formulation, optimization, and internal testing to define assay parameters, which is a different concept than an AI training set.

9. How the Ground Truth for the Training Set Was Established

As stated above, the concept of a "training set" with established ground truth in the AI/ML sense is not applicable to these chemical reagents. The "ground truth" during their development and optimization would be based on established analytical chemistry principles and performance measurements against known standards or reference materials.

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The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum using the ACE Axcel Clinical Chemistry System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum using the ACE Axcel Clinical Chemistry System. 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum using the ACE Axcel Clinical Chemistry System. Uric acid measurements 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE CK Reagent is intended for the quantitative determination of creatine kinase activity in serum using the ACE Axcel Clinical Chemistry System. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

In the ACE BUN/Urea Reagent assay, urea in serum is hydrolyzed to yield ammonia and carbon dioxide in the presence of urease. The ammonia formed then reacts with 2-oxoglutarate and NADH in the presence of glutamate dehydrogenase to yield glutamate and NAD. Two moles of NADH are oxidized for each mole of urea present. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initial rate of decrease in absorbance, monitored bichromatically at 340 nm/647 nm, is proportional to the urea concentration in the sample.

In the ACE Creatinine Reagent assay, creatinine reacts with picric acid in an alkaline medium to form a red-orange colored complex, which absorbs strongly at 505 nm. The rate of complex formation, determined by measuring the increase in absorbance bichromatically at 505 nm/573 nm during a fixed time interval, is directly proportional to the creatinine concentration in the sample.

In the ACE Uric Acid Reagent assay, uric acid in serum is oxidized by uricase to allantoin and hydrogen peroxide. The hydrogen peroxide then acts to oxdatively couple dichlorohydroxybenzene sulfonic acid and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex, which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 505 nm/610 nm, is directly proportional to the uric acid concentration in the sample.

In the ACE CK Reagent assay, serum creatine kinase initiates the conversion of creatine phosphate to creatine with the transfer of a phosphate group to adenosine diphosphate (ADP), forming ATP. The ATP is then used in the phosphorylation of D-glucose to form D-glucose-6-phosphate and ADP. This reaction is catalyzed by hexokinase. The enzyme glucose-6-phosphate dehydrogenase catalyzes the reduction of D-glucose-6-phosphate and nicotinamide adenine dinucleotide phosphate (NADP+). The series of reactions triggered by serum creatine kinase and ending in the formation of NADPH. NADPH strongly absorbs at 340 nm, whereas NADP+ does not. Therefore, the rate of conversion of NADP+ to NADPH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/378 nm. This rate of conversion from NADP+ to NADPH is a function of the activity of CK in the sample.

The ACE BUN/Urea Reagent consists of a single reagent bottle. The reagent contains alpha-ketoglutarate, urease, glutamate dehydrogenase, adenosine diphosphate (ADP), nicotinamide adenine dinucleotide and reduced (NADH).

The ACE Creatinine Reagent consists of two reagent bottles (Sodium Hydroxide Reagent and Picric Acid Reagent). The Sodium Hydroxide Reagent (R1) contains sodium hydroxide. The Picric Acid Reagent (R2) contains picric Acid.

The ACE Uric Acid Reagent consists of a single reagent bottle. The reagent contains 4-aminoantipyrine, dichlorohydroxybenzene sulfonic acid, peroxidase and uricase.

The ACE CK Reagent consists of two reagent bottles (Buffer and Substrate). The Buffer Reagent (R1) contains: imidazole buffer, glucose, N-acetyl-cysteine, magnesium acetate, EDTA, NADP and hexokinase. The Substrate Reagent (R2) contains: creatine phosphate, ADP, AMP, diadenosine pentaphosphate, EDTA and glucose-6-phosphate dehydrogenase.

This 510(k) summary describes the analytical performance of the Alfa Wassermann ACE BUN, Creatinine, Uric Acid, and CK Reagents when used with the ACE Axcel Clinical Chemistry System. The study aims to demonstrate substantial equivalence to a predicate device by evaluating precision, accuracy, and detection limits.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

The acceptance criteria for this type of device are generally understood to be that the performance of the new device (ACE Axcel System with new reagents) should be comparable to or better than a legally marketed predicate device (Alfa Wassermann ACE Clinical Chemistry System). While explicit numerical acceptance criteria are not strictly stated as "acceptance criteria" but rather as "reported performance," the goal is to show the device performs within acceptable analytical limits for clinical chemistry assays and is strongly correlated with the predicate.

Note: Acceptance criteria are implied based on typical expectations for clinical chemistry assays and the intent to demonstrate substantial equivalence to a predicate device. Specific numerical targets for acceptance were not explicitly stated in the provided text, but the strong correlation and low CVs indicate meeting such criteria.

2. Sample Sizes Used for the Test Set and Data Provenance

• ACE BUN/Urea Reagent:

  • Accuracy (Correlation Study): 113 samples (clinical laboratory), and patient correlation studies at three Physician Office Laboratory (POL) sites (number of samples not explicitly stated for POL, but implied to be sufficient for regression analysis).
  • Precision: Four BUN levels over 22 days (laboratory study), and three POL sites over 5 days (levels not specified for POL).
  • Data Provenance: Not explicitly stated, but clinical laboratory and Physician Office Laboratory (POL) settings are mentioned, suggesting human serum samples. Whether these were retrospective or prospective is not specified, but typically, method comparison studies use prospective or collected retrospective clinical samples.

• ACE Creatinine Reagent:

  • Accuracy (Correlation Study): 136 samples (clinical laboratory), and patient correlation studies at three POL sites (number of samples not explicitly stated for POL).
  • Precision: Four creatinine levels over 22 days (laboratory study), and three POL sites over 5 days (levels not specified for POL).
  • Data Provenance: Not explicitly stated, but clinical laboratory and POL settings are mentioned, suggesting human serum samples.

• ACE Uric Acid Reagent:

  • Accuracy (Correlation Study): 106 samples (clinical laboratory), and patient correlation studies at three POL sites (number of samples not explicitly stated for POL).
  • Precision: Four uric acid levels over 22 days (laboratory study), and three POL sites over 5 days (levels not specified for POL).
  • Data Provenance: Not explicitly stated, but clinical laboratory and POL settings are mentioned, suggesting human serum samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement of chemical analytes (BUN, Creatinine, Uric Acid, CK) in serum. The 'ground truth' for such devices is established by a reference method or a legally marketed predicate device, not by expert interpretation of images or clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is an IVD device for quantitative chemical analysis. Adjudication methods are typically used for qualitative or interpretive diagnostic devices where human expert disagreement might occur (e.g., radiology, pathology). Here, the comparison is directly numerical between the candidate device and the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is an IVD device for laboratory chemical analysis, not an imaging or interpretive diagnostic device that involves human readers or AI assistance in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The described studies evaluate the performance of the algorithm/system only (the ACE Axcel Clinical Chemistry System with the new reagents) in quantifying the analytes in serum. The performance data (precision, accuracy, detection limit) are intrinsic to the device's analytical capability, independent of human interpretation of the results for the purpose of generating the values themselves. While trained personnel operate the system, the analytical performance is measured as a standalone function of the device.

7. The Type of Ground Truth Used

The "ground truth" for the accuracy studies was established by comparing the results from the Alfa Wassermann ACE Axcel Clinical Chemistry System (the new device, 'y') to a legally marketed predicate device, the Alfa Wassermann ACE Clinical Chemistry System ('x'). This is a common method for IVD substantial equivalence, where the predicate is considered the accepted reference for performance. For detection limits, it would typically involve analyzing samples with known, very low concentrations of the analytes or diluting higher concentration samples to determine the lowest measurable level.

8. The Sample Size for the Training Set

The provided text describes performance validation studies, not the development or training of an algorithm in the machine learning sense. Therefore, there is no "training set" for an algorithm to learn from in this context. The study focuses on verifying the performance of the already-developed reagent and instrument system.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the machine learning sense for this type of IVD device submission.

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