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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 S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. 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 or physician office laboratories. For in vitro diagnostic use only.

The S-Test Lactate Dehydrogenase (LD) reagent cartridge, used with the S40 Clinical Analyzer, is intended for the quantitative in vitro diagnostic determination of LD activity in serum based on a photometric test measuring the rate of conversion of NADH from NAD in an enzyme assay. It is composed of a bi-reagent cartridge, and is intended for use in clinical laboratories or physician office laboratories.

The S-Test LD Reagent cartridge is intended for the quantitative in vitro diagnostic determination of LD activity in serum, used with the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases (e.g., acute viral hepatitis, cirrhosis, metastatic carcinoma of the liver), cardiac diseases (e.g., myocardial infarction), and tumors of the lung or kidneys.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

• Correlation coefficient: 0.9857
• Standard error estimate: 19.8
• Confidence interval slope: 0.934 to 1.008
• Confidence interval intercept: -13.3 to 2.7
  POL sites (4 sites):
• Correlation coefficients: 0.9971 to 0.9989
• Standard error estimates: 6.4 to 10.5
• Confidence interval slopes: 0.941 to 1.001
• Confidence interval intercepts: -11.1 to 11.0 |
  | Detection Limit | Low (e.g., clinically relevant lower bound) | 9 U/L |

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

• Sample Size for Accuracy Study (In-house): 81 samples
• Sample Size for Accuracy Studies (POL sites): Not explicitly stated, but implies multiple samples were tested at each of the four separate POL sites.
• Sample Size for Precision Study (In-house): Not explicitly stated how many individual measurements contributed to the CVs, but involved testing at three LD levels over 22 days.
• Sample Size for Precision Study (POL sites): Not explicitly stated, but involved testing at three separate POL sites over 5 days.
• Data Provenance: The studies were conducted "in-house" (presumably by Alfa Wassermann Diagnostic Technologies, LLC, in the US) and at "three separate Physician Office Laboratory (POL) sites" and "four separate POL sites," indicating that data was collected from various clinical settings. Given the submitter's location in New Jersey, USA, and the FDA submission, it's highly probable the data is from the United States. The studies appear to be prospective as performance specific to this device and its use with the S40 Clinical Analyzer was generated.

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) device for quantitative biochemical measurement. The "ground truth" for the test set is established by a comparative, legally marketed method (Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Lactate Dehydrogenase Reagent), not by expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. As this is an IVD device measuring a biochemical marker against a comparative method, there is no human adjudication involved in establishing the "ground truth." The comparison is a direct numerical correlation between the S-Test LD and the predicate device.

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

Not applicable. This device is an in vitro diagnostic test for quantitative determination of an analyte (LD activity). MRMC studies are typically performed for diagnostic imaging or pathology devices where human readers interpret medical images or samples.

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

Yes, this describes the primary performance evaluation. The S-Test LD Reagent cartridge, when used with the S40 Clinical Analyzer, performs the quantitative measurement of LD activity without human interpretation in the results generation. The performance data presented (precision, accuracy, detection limit) are direct technical performance characteristics of the device itself.

7. Type of Ground Truth Used

The ground truth for the performance studies was established by comparison to a legally marketed predicate device (Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Lactate Dehydrogenase Reagent) using the "comparative method." This is a common and accepted method for establishing the performance equivalence of new IVD assays.

8. Sample Size for the Training Set

Not applicable. This is a biochemical reagent and analyzer system, not a machine learning or AI-based device that requires a "training set" in the conventional sense of artificial intelligence. The device's operational parameters and calibration procedures are established through manufacturing and quality control, not through a data training pipeline.

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

Not applicable. As mentioned above, there is no "training set" for this type of IVD device in the context of machine learning. The operational characteristics and performance specifications are inherent to the chemical reactions and instrumental design, validated through standard analytical performance studies.

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The Piccolo Lactate Dehydrogenase Test System (presently contained on the Piccolo Basic Metabolic Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate dehydrogenase activity in heparinized plasma or serum in a clinical laboratory setting or point-of-care location.

Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis and cirrhosis; cardiac diseases such as myocardial infarction; malignant diseases; and tissue alterations of the heart, kidney, liver, and muscle.

The Piccolo Basic Metabolic Panel Plus Reagent Disc (which contains the Piccolo Lactate Dehydrogenase Test System) is designed for heparinized plasma and serum, only. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted samples mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.

Here's an analysis of the provided text to extract information about the device's acceptance criteria and the supporting study, formatted as requested:

Device: Piccolo® Lactate Dehydrogenase Test System

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance targets (e.g., "linearity must be >0.99"). Instead, it presents the results of linearity and precision studies. The implicit acceptance criteria would be for these results to demonstrate performance comparable to the predicate device and suitable for its intended use.

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

• Linearity: Sample size not explicitly stated beyond the reported slope, intercept, and correlation coefficient.
• Precision:
  • Sample Size: n = 80 for both within-run and total precision studies.
• Sample Type Comparison: Sample size not explicitly stated.
• Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin. Given it's a 510(k) submission for a US market, studies would typically be conducted to meet US regulatory requirements. It is a non-clinical study since it involves comparing the device to a predicate device in a laboratory setting.

3. Number of Experts Used and Their Qualifications for Ground Truth

Not applicable. This is a non-clinical study evaluating the performance of a laboratory diagnostic device, not a diagnostic imaging or AI algorithm requiring expert interpretation for ground truth. The "ground truth" for linearity and precision would be derived from certified reference materials or established high-accuracy laboratory methods.

4. Adjudication Method for the Test Set

Not applicable, as this is a non-clinical laboratory device performance study, not a clinical trial or AI study involving human interpretation.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance (linearity, precision) of a laboratory assay, not on the effectiveness of human readers with or without AI assistance.

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

Yes, the studies reported (Linearity, Precision, Sample Type Comparison) represent the standalone performance of the Piccolo® Lactate Dehydrogenase Test System. These are analytical studies of the device itself, without human interpretation as part of the performance metric.

7. Type of Ground Truth Used

• Linearity, Precision, and Sample Type Comparison: The ground truth would be established using reference methods or certified calibrators/control materials with known concentrations/activities of Lactate Dehydrogenase. For precision, the "true" value is the mean value obtained over multiple runs. For sample type comparison, the "true" value is derived from a comparative method or the predicate device if it's considered the reference.

8. Sample Size for the Training Set

Not applicable. This is a non-AI/ML medical device submission. Therefore, there is no "training set" in the context of machine learning. The device's calibration is based on "Bar code with factory calibrated lot specific data."

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

Not applicable, as there is no training set for an AI/ML algorithm. The device uses "factory calibrated lot specific data" for its calibration, which would be established during manufacturing and quality control processes using reference materials and established laboratory standards.

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For the quantitative determination of Lactate Dehydrogenase in serum. For IN VITRO diagnostic use. Elevated levels of lactate dehydrogenase are clinically significant and can be found in disease states which result in cell damage. Myocardial infarcts, liver disease, megaloblastic anemias, renal disease, progressive muscular dystrophy and some malignancies all produce elevated lactate dehydrogenase values in serum (1).

Lactate Dehydrogenase-SL Assay

This document is a 510(k) clearance letter from the FDA for a medical device called "Lactate Dehydrogenase-SL Assay". It does not describe acceptance criteria, the results of a study to prove the device meets acceptance criteria, or any of the other specific details requested in the prompt.

The letter states that the FDA has reviewed the 510(k) notification and determined that the device is substantially equivalent to legally marketed predicate devices. This means that the device is considered safe and effective for its intended use based on its similarity to existing devices.

To provide the information requested in the prompt, a study report or a different section of the 510(k) submission that details the performance data would be needed. This document only provides the regulatory clearance.

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This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of Lactate dehydrogenase in serum or leomonogram in the for in vitro diagnostic use only. The determination of Lactate dehydrogenase in serum is most commonly performed for the diagnosis and treatment of myocardial infarctions. LD elevations are also observed in liver disease, pernicious anemia, some cases of renal disease, and in cases of skeletal muscle trauma.

Liquid LDH-L Reagent Set

The provided text is a 510(k) premarket notification letter from the FDA regarding a "Liquid LDH-L Reagent Kit." This document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a 510(k) summary.

Therefore, I cannot extract the information required to populate the table and answer the questions. The letter only confirms that the device is substantially equivalent to a predicate device and can be marketed. It refers to "indications for use stated in the enclosure," but the enclosure itself is a simple "Indications for Use" statement and does not contain the requested study details.

To answer your request, I would need a different document, such as the 510(k) summary or the full submission, which would detail the studies performed to demonstrate substantial equivalence.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device