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The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Alera Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE Total Iron Reagent is intended for the quantitative determination of iron in serum using the ACE Alera Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE LDH-L Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the ACE Alera Clinical Chemistry System. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct TIBC Color Reagent, an acidic buffer containing an iron-binding dye and ferric chloride, is added to the serum sample. The low pH of Direct TIBC Color Reagent releases iron from transferrin. The iron then forms a colored complex with the dye. The colored complex at the end of the first step represents both the serum iron and excess iron already present in Direct TIBC Color Reagent. Direct TIBC Buffer, a neutral buffer, is then added, shifting the pH and resulting in a large increase in the affinity of transferrin for iron. The serum transferrin rapidly binds the iron by abstracting it from the dye-iron complex. The observed decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the serum sample. The absorbance is measured at 647 nm.

In the ACE Total Iron Reagent assay, transferrin-bound iron in serum is released at an acidic pH and reduced from ferric to ferrous ions. These ions react with ferrozine to form a violet colored complex, which is measured bichromatically at 554 nm/692 nm. The intensity of color produced is directly proportional to the serum iron concentration.

In the ACE LDH-L Reagent assay, lactate dehydrogenase catalyzes the conversion of L-lactate to pyruvate. Nicotinamide adenine dinucleotide (NAD+) acts as an acceptor for the hydrogen ions released from the L-lactate and is converted to reduced nicotinamide adenine dinucleotide (NADH). NADH absorbs strongly at 340 nm whereas NAD+ does not. Therefore, the rate of conversion of NAD+ to NADH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NAD+ to NADH is directly proportional to the lactate dehydrogenase activity in the sample.

The provided document describes in vitro diagnostic (IVD) reagents (ACE Direct Total Iron-Binding Capacity (TIBC) Reagent, ACE Total Iron Reagent, and ACE LDH-L Reagent) for use on the ACE Alera Clinical Chemistry System. The acceptance criteria and performance data presented relate to the analytical performance of these reagents/systems, specifically their ability to accurately and precisely measure analytes in serum samples.

Crucially, this is not a study about an AI/ML powered medical device. Therefore, many of the typical acceptance criteria and study aspects requested in your prompt regarding AI/ML (e.g., ground truth established by experts, multi-reader multi-case studies, human-in-the-loop performance, training/test set sample sizes for AI, adjudication methods) are not applicable to this type of device and submission.

The "study" described here is a series of analytical performance tests (linearity, precision, method comparison, detection limits, interference) to demonstrate that the new device (ACE Alera system with these reagents) performs comparably to the predicate device (ACE Clinical Chemistry System with the same reagents) and meets established analytical performance specifications for clinical chemistry assays.

Here's a breakdown of the relevant information from the document in the format you requested, with an explanation of why certain AI/ML-centric points are not applicable:

Device: ACE Direct Total Iron-Binding Capacity (TIBC) Reagent, ACE Total Iron Reagent, ACE LDH-L Reagent (for use on ACE Alera Clinical Chemistry System)

1. Table of acceptance criteria and reported device performance:

Since the document does not explicitly present "acceptance criteria" alongside "reported performance" in a single table, I will infer the acceptance criteria from the context of method comparison, linearity, and precision studies, which are standard for IVD device validation, often aiming for performance comparable to predicate devices or within clinically acceptable limits. The reported performance is directly extracted from the tables provided.

Interference:
The acceptance criterion for interference studies in IVD assays is typically that the interferent, up to a specified concentration, does not cause a "significant interference" (e.g., a bias exceeding a defined clinical or analytical threshold). The document lists the concentrations at which no significant interference was observed.

Precision (POL - Point of Care/Physician Office Lab):
Similar to in-house precision, specific %CV or SD limits would be the acceptance criteria. The data shows results from 3 POLs compared to in-house.

Method Comparison (POLs vs. In-House (ACE Alera (x) vs. POL ACE Alera (y))):
Similar to the in-house method comparison, the acceptance criteria are for slopes to be near 1, intercepts near 0, and high correlation coefficients (e.g., >0.99), indicating consistent performance across different lab environments.

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

• Sample Sizes for analytical performance studies (Test Set):

  • Method Comparison:
    • TIBC: 50 samples
    • Iron: 48 samples
    • LDH-L: 58 (in-house comparison) / 51 (POL comparison) samples
  • Linearity: The number of samples/levels for linearity is not explicitly stated as 'n', but standard practice involves multiple levels (typically 5-7) prepared from diluted/spiked samples.
  • Precision: Standard runs (e.g., 2 runs per day for 20 days for total precision, with replicates per run for within-run precision) would involve a substantial number of measurements (e.g., 20 days x 2 runs/day x 2 replicates/run = 80 measurements per level). The POL precision data shows n=20, likely referring to 20 days of testing.
  • Interference: The number of samples used for interference studies is not explicitly stated.

• Data Provenance: "In-House" and "POL" (Physician Office Laboratories). The specific country of origin is not explicitly stated, but given the company's location (New Jersey, USA) and FDA 510(k) submission, it's highly likely to be United States. The studies are prospective analytical validation studies, meaning the data was collected specifically to demonstrate the performance of the device.

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

Not applicable. This is an in vitro diagnostic (IVD) chemistry analyzer and reagent system. "Ground truth" for IVD analytical performance is established by reference methods, certified reference materials, or highly accurate comparative methods, not by human expert consensus or radiologists. The performance is assessed against quantitative values, not qualitative interpretations requiring expert review.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., imaging studies where radiologists disagree). For analytical performance of a chemistry analyzer, the "ground truth" is typically the quantitative value obtained from a reference method or the predicate device, and differences are assessed statistically (e.g., bias, correlation).

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. MRMC studies are specific to evaluating the impact of a device on human readers' performance, typically in diagnostic imaging with AI assistance. This device is an automated chemistry analyzer, not an AI-assisted diagnostic imaging tool. There are no human "readers" in the context of this device's operation.

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

Yes, in essence. The performance data provided (linearity, precision, detection limits, interference, method comparison) represents the "standalone" analytical performance of the automated chemistry system (ACE Alera with the new reagents) in measuring the target analytes in patient samples. There isn't an "algorithm only" in the AI sense, but the chemical reactions and photometric measurements are entirely automated by the device. The data shown is the raw analytical output.

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

The "ground truth" for these analytical studies is primarily:

• Highly characterized samples: For linearity, samples with known, precise concentrations (often prepared by dilution of high-concentration materials or spiking low-concentration materials).
• Comparative method/Predicate device: For method comparison, the results generated by the predicate device (ACE Clinical Chemistry System) are treated as the reference or comparative method against which the new ACE Alera system's results are compared. This is a common and accepted "ground truth" for chemical analyzers seeking substantial equivalence.
• Reference materials/controls: For precision and detection limits, control materials with established target values are used.

8. The sample size for the training set:

Not applicable. This is a traditional IVD device (chemical reagents and analyzer), not an AI/ML device that requires a "training set" in the context of machine learning model development. The reagents perform chemical reactions, and the analyzer reads photometric changes; it does not "learn" from data.

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

Not applicable, as there is no training set in the AI/ML sense for this device.

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The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.

The ACE TIBC Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Axcel Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Serum Iron Reagent is intended for the quantitative determination of iron concentration in serum using the ACE Axcel Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Lipase Reagent is intended for the quantitative determination of lipase activity in serum using the ACE Axcel Clinical Chemistry System. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct. 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 Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct TIBC Color Reagent, an acidic buffer containing an iron-binding dye and ferric chloride, is added to the serum sample. The low pH of Direct TIBC Color Reagent releases iron from transferrin. The iron then forms a colored complex with the dye. The colored complex at the end of the first step represents both the serum iron and excess iron already present in Direct TIBC Color Reagent. Direct TIBC Buffer, a neutral buffer, is then added, shifting the pH and resulting in a large increase in the affinity of transferrin for iron. The serum transferrin rapidly binds the iron by abstracting it from the dye-iron complex. The observed decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the serum sample. The absorbance is measured at 647 nm.

In the ACE Serum Iron Reagent assay, transferrin-bound iron in serum is released at an acidic pH and reduced from ferric to ferrous ions. These ions react with ferrozine to form a violet colored complex, which is measured bichromatically at 554 nm/692 nm. The intensity of color produced is directly proportional to the serum iron concentration.

In the ACE Lipase Reagent Assay, serum lipase acts on a natural substrate, 1,2-diglyceride, to liberate 2-monoglyceride. This is hydrolyzed by monoglyceride lipase (a highly specific enzyme for monoglyceride) into glycerol and free fatty acid. Glycerol kinase acts on glycerol to form glycerol-3-phosphate, which is in turn acted on by glycerol-3-phosphate oxidase to generate hydrogen peroxide. Peroxidase converts the hydrogen peroxide, 4-Aminoantipyrine and TOOS (N-ethyl-N-(2-hydroxy-3-sulfopropyl)-m-toluidine) into a quinine dye. The rate of formation of the dye, determined bichromatically at an absorbance of 573 nm/692 nm, is proportional to the lipase activity in the sample.

Here's a breakdown of the acceptance criteria and study information for the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent, ACE Serum Iron Reagent, and ACE Lipase Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Within-run CV: 0.9% to 2.2%
• Total CV: 2.0% to 3.3%
  POL Sites:
• Within-run CV: 0.9% to 3.4%
• Total CV: 0.9% to 4.1% |
  | Accuracy (Correlation to Predicate) | High correlation coefficient, low standard error, slope near 1, intercept near 0 when compared to predicate device. | Lab (109 samples):
• Correlation Coefficient: 0.9950
• Standard Error Estimate: 9.1
• Confidence Interval Slope: 0.961 to 0.998
• Confidence Interval Intercept: -9.2 to 4.3
  POL Sites:
• Correlation Coefficients: 0.9902 to 0.9987
• Standard Error Estimates: 6.1 to 11.2
• Confidence Interval Slopes: 0.923 to 1.006
• Confidence Interval Intercepts: -8.2 to 19.4 |
  | Detection Limit | Low enough to be clinically useful. | 42.21 µg/dL |
  | ACE Serum Iron Reagent |
  | Precision | Low within-run and total CV for various Serum Iron levels. | Lab Testing:
• Within-run CV: 1.2% to 5.2%
• Total CV: 1.3% to 5.4%
  POL Sites:
• Within-run CV: 1.2% to 4.1%
• Total CV: 1.2% to 4.2% |
  | Accuracy (Correlation to Predicate) | High correlation coefficient, low standard error, slope near 1, intercept near 0 when compared to predicate device. | Lab (130 samples):
• Correlation Coefficient: 0.9995
• Standard Error Estimate: 3.3
• Confidence Interval Slope: 1.000 to 1.012
• Confidence Interval Intercept: -2.7 to -1.0
  POL Sites:
• Correlation Coefficients: 0.9992 to 0.9998
• Standard Error Estimates: 6.1 to 11.2
• Confidence Interval Slopes: 0.997 to 1.041
• Confidence Interval Intercepts: -2.7 to 9.2 |
  | Detection Limit | Low enough to be clinically useful. | 5.08 µg/dL |
  | ACE Lipase Reagent |
  | Precision | Low within-run and total CV for various lipase levels. | Lab Testing:
• Within-run CV: 1.1% to 6.5%
• Total CV: 6.0% to 10.7%
  POL Sites:
• Within-run CV: "to 7.3%" (lower bound not specified)
• Total CV: 1.9% to 7.3% |
  | Accuracy (Correlation to Predicate) | High correlation coefficient, low standard error, slope near 1, intercept near 0 when compared to predicate device. | Lab (107 samples):
• Correlation Coefficient: 0.9980
• Standard Error Estimate: 9.06
• Confidence Interval Slope: 0.970 to 0.994
• Confidence Interval Intercept: 1.97 to 5.97
  POL Sites:
• Correlation Coefficients: 0.9993 to 0.9997
• Standard Error Estimates: 4.44 to 7.89
• Confidence Interval Slopes: 1.002 to 1.047
• Confidence Interval Intercepts: -4.74 to 3.41 |
  | Detection Limit | Low enough to be clinically useful. | 10.63 U/L |

Note: The acceptance criteria are "implied" because the document primarily presents the results of the performance data without explicitly stating the pre-defined target values or ranges that were aimed for. However, the context of a 510(k) submission requires demonstrating substantial equivalence, meaning the performance should be comparable to the predicate device. Therefore, the reported data, particularly the high correlation coefficients, slopes near 1, and intercepts near 0 for accuracy, indicate that these outcomes met whatever internal acceptance criteria were set for demonstrating equivalency. For precision, low CVs are generally accepted as good performance.

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

• ACE Direct Total Iron-Binding Capacity (TIBC) Reagent:

  • Sample Size:
    • Accuracy (correlation study): 109 samples
    • Precision (lab): 4 TIBC levels tested for 22 days.
    • Precision (POL sites): 3 separate POL sites, testing over 5 days (number of samples not specified, but likely multiple runs per site per day).
  • Data Provenance: Not explicitly stated, but the testing occurred at "Physician Office Laboratory (POL) sites" and an unnamed central lab. It is not specified if the data is retrospective or prospective, nor the country of origin.

• ACE Serum Iron Reagent:

  • Sample Size:
    • Accuracy (correlation study): 130 samples
    • Precision (lab): 4 Serum Iron levels tested for 22 days.
    • Precision (POL sites): 3 separate POL sites, testing over 5 days (number of samples not specified).
  • Data Provenance: Not explicitly stated, but testing occurred at "Physician Office Laboratory (POL) sites" and an unnamed central lab. Retrospective or prospective nature and country of origin are not specified.

• ACE Lipase Reagent:

  • Sample Size:
    • Accuracy (correlation study): 107 samples
    • Precision (lab): 3 lipase levels tested for 22 days.
    • Precision (POL sites): 3 separate POL sites, testing over 5 days (number of samples not specified).
  • Data Provenance: Not explicitly stated, but testing occurred at "Physician Office Laboratory (POL) sites" and an unnamed central lab. Retrospective or prospective nature and country of origin are not specified.

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

This information is not provided in the given text. The ground truth for these types of in vitro diagnostic tests is typically established by measurements from a reference method or a predicate device. The text indicates that the "Alfa Wassermann ACE Clinical Chemistry System" was used as the comparator (predicate device) (referred to as 'x' in the regression analyses).

4. Adjudication Method for the Test Set

This information is not applicable and therefore, not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation, such as by human readers of medical images, to resolve discrepancies in diagnoses. These clinical chemistry devices produce quantitative numerical results, which are then compared statistically to a reference method or predicate device, rather than adjudicated.

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 as the described devices are in vitro diagnostic clinical chemistry reagents and an automated system (ACE Axcel Clinical Chemistry System), not AI-assisted imaging or diagnostic tools designed for human readers to interpret. Therefore, an MRMC study and effects on human reader performance are not relevant to this submission.

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

Yes, the studies described are standalone performance studies of the device and reagents. The ACE Axcel Clinical Chemistry System is an "automated, discrete, bench-top, random access analyzer." The performance data presented (precision, accuracy, detection limit) are measurements of the system's ability to quantitatively determine analytes directly, without a human interpretation step that would introduce a "human-in-the-loop" component in the result generation itself. The results quantify the device's inherent measurement capabilities.

7. The Type of Ground Truth Used

The ground truth for these studies was established by comparison to a legally marketed predicate device, the "Alfa Wassermann ACE Clinical Chemistry System" (specifically, the ACE Reagents K000781, K944911 run on the K931786 system). This is a common method for demonstrating substantial equivalence for in vitro diagnostic devices in 510(k) submissions. The new device's measurements (y) were correlated against the predicate device's measurements (x).

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in the context of these types of in vitro diagnostic submissions for clinical chemistry reagents and analyzers. The device described does not employ a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a device primarily involves rigorous internal calibration procedures and validation during its development and manufacturing, which are distinct from the concept of a "training set" for AI/ML models.

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

As explained in point 8, the concept of a "training set" requiring ground truth establishment in this manner is not applicable to this type of device and submission. The device's operational parameters are set through design, engineering, and calibration processes, not machine learning model training.

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The Vitalab Iron Reagent Kit, which contains both reagent and calibrator, is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of total iron in serum and plasma. Iron results may be used for the diagnosis and treatment of diseases associated with iron metabolism such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

The Vitalab Iron Reagent Kit and the Vitalab Selectra Analyzer are used as a system for the quantitative determination of total iron in serum and plasma. Iron in the sample is specifically released from transferrin using an acidic buffer. The released iron is then reduced and reacts with a chromogenic indicator. The increase in absorbance at 578 nm is measured photometrically. The increase in absorbance at 578 nm is proportional to the iron concentration of the sample.

The provided text describes the acceptance criteria and study for the Vitalab Iron Reagent Kit and Vitalab Selectra Analyzer, which are used as a system for the quantitative determination of total iron in serum and plasma.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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The ATAC Iron Reagent Kit, which contains both reagent and calibrator, is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of total iron in serum. The ATAC TIBC Column Kit, which is marketed with generic labeling and an ATAC 8000 Application Sheet, is intended for use with the ATAC Iron Reagent Kit and other iron reagents for the quantitative determination of total iron binding capacity in serum.

Total iron results are used for the diagnosis and treatment of diciency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, and characterized by pigmentation of the skin), and chronic renal disease. Total iron binding capacity measurements are used for the diagnosis and treatment of anemia.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC Iron Reagent measures total serum iron by stripping it from the transferrin in a low pH reagent buffer, oxidizing it to ferric ions and binding it with Ferrozine. The resulting increase in absorbance at 546 nm is proportional to the iron concentration in the sample. The ATAC TIBC Column Kit is used to pretreat serum specimens prior analysis. The iron in the saturating reagent ensures that all available iron binding sites in the serum specimen are saturated with iron. The filtrate is assayed with an iron reagent after removing the unbound iron form the sample mixture by passing it through an alumina column. The maximum amount of iron bound in the specimen is a measure of its transferrin concentration.

The provided document describes the ATAC Iron Reagent Kit and ATAC TIBC Column Kit for quantitative determination of total iron and total iron binding capacity in serum. The study aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study particulars:

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state pre-defined acceptance criteria, but rather presents performance characteristics of the device and claims substantial equivalence to predicate devices. The "reported device performance" are the results of the effectiveness and precision studies.

ATAC Iron Reagent Kit Performance:

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