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The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.

The Access Ferritin assay is a sandwich immunoenzymatic assay. The Access Ferritin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Ferritin assay reagent pack, Access Ferritin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

Device Name: Access Ferritin

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size (Method Comparison): 147 samples
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the method comparison samples. It only mentions "patient samples" in the context of the CLSI guidance document referenced (CLSI EP09c: Measurement Procedure Comparison and Bias Estimation Using Patient Samples).
• Test Set Sample Size (Precision, LoB, LoD, LoQ):
  • Precision: 80 replicates for each of the 6 concentration levels (1.2, 13, 147, 289, 560, 1276 ng/mL) are reported in the table. The study design mentions "tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days," which would result in 80 measurements (2 replicates x 2 runs/day x 20 days).
  • LoB: 75 replicates of native samples.
  • LoD: Five to nine serum samples containing low levels of Ferritin analyte, tested over five days with one run per day and nine replicates per run for each pack lot (resulting in ≥ 40 replicates minimally required for LoD estimation for each sample on each pack lot tested).
  • LoQ: Eight to twelve serum samples containing low levels of Ferritin analyte, tested in replicates of nine per run with one run per day and five total days on each pack lot and instrument (resulting in a minimum of 40 replicates for each sample on each pack lot).
• Provenance for Precision, LoB, LoD, LoQ: Not specified, other than "native samples" or "serum samples."

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

This device is an in-vitro diagnostic (IVD) immunoassay for quantitative determination of ferritin levels. Ground truth for such devices is typically established through reference methods or established laboratory gold standards rather than expert consensus on interpretive tasks. The document does not mention any involvement of human experts or radiologists in establishing ground truth for the test set performance evaluation. The "ground truth" here would be the actual ferritin concentration as determined by the predicate device (for method comparison) or highly controlled, characterized samples (for precision, linearity, limits).

4. Adjudication Method for the Test Set

Not applicable. As an IVD immunoassay, the "ground truth" or reference values are determined by laboratory measurements, not by human expert adjudication in the traditional sense (e.g., 2+1 for image interpretation).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic imaging or similar interpretive tasks involving multiple human readers. This document describes the performance evaluation of an automated immunoassay system, which does not involve human readers interpreting results in the same way.

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

Yes. The entire study describes the standalone performance of the Access Ferritin assay on the Dxl 9000 Access Immunoassay Analyzer. This is an automated system; the performance metrics (method comparison, precision, linearity, limits) are intrinsic to the assay and instrument combination without human intervention in the result generation or interpretation other than standard lab operating procedures.

7. The Type of Ground Truth Used

• Method Comparison: The "ground truth" or reference values for the method comparison study were obtained from the predicate device, the Access Ferritin assay run on the Access Immunoassay System (K926221/K052082).
• Precision, Linearity, LoB, LoD, LoQ: Ground truth for these studies was established using characterized samples (e.g., samples with known or carefully prepared concentrations, native low-level samples, or blank samples). These are standard practices in IVD analytical performance evaluation.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. This is an immunoassay, not a device that uses AI models that require traditional training data. The development of the assay and its associated reagents/software would have involved internal R&D studies, but these are not described as a "training set" in the common AI sense.

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

Not applicable, as this is not an AI/ML device with a distinct "training set" as described in AI development. The "ground truth" for developing the assay itself would have involved extensive biochemical and analytical characterization in a laboratory setting.

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The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and postanalytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.

The DxI 800 Access Immunoassay System is a microcomputer controlled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative or qualitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxI 800 System is an in vitro diagnostic device for use in the clinical laboratory.

The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum and plasma (heparin) or red blood cells using the Access Immunoassay Systems. Folate levels in serum and plasma (heparin) or red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. This assay is capable of providing 3rd generation TSH results. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.

The DxA system is a high throughput automated sample handling system which can perform the pre and post analytical processing of sample tubes. DxA can identify and track samples, perform centrifugation, decapping, delivery of samples to connected analyzers, recapping, storing in either non-refrigerated or refrigerated storage, and sorting to output racks.

The DxA integrates perianalytic (pre and post analysis) functions with analytical instruments (Beckman Coulter, and other manufacturer's) via a track system to provide fully integrated testing solutions.

This document focuses on the substantial equivalence of the DxA 5000 automated sample handling system and related immunoassay tests (Ferritin, Folate, TSH, Vitamin B12) to previously cleared devices. It describes engineering performance studies rather than clinical efficacy studies. Therefore, many of the typical clinical study criteria requested (like multi-reader multi-case studies, effect size of human improvement with AI, number of experts for ground truth, sample size for training sets) are not applicable or detailed in this submission.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document states that "The acceptance criteria were met for all method comparisons thereby demonstrating the following:"

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

• Sample Size: The document does not specify the exact sample sizes used for the method comparison studies. It mentions that the studies utilized CLSI EP09, which is a guideline for method comparison and bias estimation using patient samples, but the number of samples is not disclosed.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). However, given it's a 510(k) submission for an in vitro diagnostic device, the studies are typically conducted in a controlled laboratory setting, often in a prospective manner or using banked samples that meet specific criteria.

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

This information is not applicable and not provided in the document. The acceptance criteria and performance relate to the comparability of the new automation system and immunoassay tests against predicate devices, not against a "ground truth" established by experts for diagnostic accuracy in a clinical setting in the way an AI imaging device might. The "ground truth" here is the performance of the predicate device/system.

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

This information is not applicable and not provided. Adjudication methods are typically used in studies where human readers are interpreting data (e.g., medical images) and their interpretations need to be reconciled to establish a consensus ground truth. This is an engineering/analytical performance study for a laboratory automation system and immunoassay tests.

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 and not provided. MRMC studies are relevant for imaging devices where human readers are involved in the diagnostic process. This document concerns a laboratory automation system and immunoassay tests, not an AI-assisted diagnostic imaging tool.

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

The studies described are for the performance of the integrated system (DxA 5000 connected to the DxI 800 Access Immunoassay System running specific assays). While the system operates largely automatically (an "algorithm only" in the sense that the mechanical and analytical processes are automated), its performance is compared to a human-operated predicate system or another automated system. This is not an "AI algorithm only" study in the context of diagnostic decision support, but rather an automated analytical system comparison.

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

The "ground truth" in this context is the performance of the legally marketed predicate devices/systems:

• Power Processor Sample Processing System (K110413) for the DxA 5000's automation features.
• Beckman Coulter UniCel® DxI 800 Access® Immunoassay System (K023764), Access® Ferritin assay (K926221), Access® Folate assay (K060774), Access® HYPER sensitive hTSH assay (K042281), and Access® Vitamin B12 assay (K955436) for the immunoassay performance in conjunction with the automation system.

The study aimed to demonstrate that the new device system yielded results "within specifications" when compared to the predicate, implying the predicate's performance served as the benchmark or "ground truth" for equivalence.

8. The sample size for the training set

This information is not applicable and not provided. This is a 510(k) submission for laboratory equipment and assays, not a machine learning/AI device requiring a "training set" in the computational sense. The "development" for such systems involves rigorous engineering, analytical validation, and verification based on established chemical, biological, and mechanical principles.

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

This information is not applicable for the reasons stated in point 8.

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The basic Power Express is an automated sample handling system which processes sample tubes from the precentrifugation, pre-sorting step to presentation of centrifuged and decapped samples into Generic or Personality Racks for specific instruments. The Power Express can be configured with optional software to allow processing of sample tubes on Generic Connection Instruments. The Power Express performs all pre-analytical sample tube preparation, and then sorts the sample tubes directly to Generic Connection Modules where the samples are pipetted by the Generic Connection instrument for testing. After the samples are pipetted, the tubes can route to other instruments for additional testing or to Outlet Racks.

The UniCel DxI 800 Access Immunoasav System with laboratory automation is a microcomputer-controlled. random and continuous access analyzer that includes an external computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for determination of various analytes, such as Vitamin B12. Ferritin, Folate and hTSH along with other various enzyme immunoassays assays that may be adaptable to the analyzer depent used to induce the enzyme immunoassay reaction. The UniCel Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory.

The Access Ferritin assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

The Access HYPER sensitive hTSH assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of vitamin B12 in human serum and plasma (heparin) using Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.

The Power Express is Beckman Coulter's Power Processor Sample Processing System with the modifications noted in this premarket submission. The Power Express and the Power Processor Sample Processing System are scalable laboratory automation systems (LAS) designed to streamline peri-analytical processes in the clinical laboratory.

The Power Express is an automated sample handling system which processes sample tubes from the pre-centrifugation, pre-sorting steps to presentation of centrifuged and decapped samples into racks for chemistry, immunoassay, hematology, and coagulation systems. The Power Express is designed to free laboratory personnel from biohazard exposure and routine sample preparation.

The Power Express software can be configured with optional hardware to allow processing of sample tubes on physically connected analyzers using common communication protocols (Generic Connection Instruments). The Power Express performs pre-analytical sample tube preparation then sorts the sample tubes directly to the optional hardware interface between the LAS and analyzer (Generic Connection Module) where the samples are pipetted by the analyzer for testing. After the samples are pipetted, the tubes can be routed to other instruments for additional testing or to Outlet Racks.

A basic Power Express System is comprised of a Line Control Computer, a system console with Cennexus software, Inlet Module, Centrifugation Module, Decapper Module, track transport system and Outlet Module. Additional modules may be added for aliquot capability, sample capping, and ambient or refrigerated storage.

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the efficacy of new clinical features from scratch. This influences the nature of the "acceptance criteria" and "study" described. The document largely asserts that the modifications to the Power Processor system did not introduce new risks to the performance of the integrated assays, and therefore formal V&V testing was sufficient rather than full clinical studies.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" in the traditional sense of numerical thresholds for clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" can be inferred from the statement that "all software design, development and verification activities have been completed and passed to supports equivalency of Power Express to the Power Processor V5.0 Sample Processing System." The performance reported is that the device "functions as intended, meeting the requirements of the design specifications."

Let's infer acceptance criteria based on the modifications and the intent of substantial equivalence:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for test sets in the context of clinical or performance data for the assays themselves. The testing described is primarily software and system verification and validation (V&V). These are typically internal engineering tests rather than studies involving patient samples in a clinical setting with formal sample sizes as understood in clinical trials.

• Sample Size for Test Set: Not specified, as the testing was primarily V&V of the automated system's components and software.
• Data Provenance: Not applicable in the context of system V&V. This would typically be relevant for clinical studies involving patient data. This was internal Beckman Coulter testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of V&V testing described. "Ground truth" in this context would likely refer to expected system behaviors, software outputs, or known operational parameters, which would be established by the device's design specifications and engineering teams, rather than by external clinical experts.

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

Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions on diagnosis or outcome. For system V&V, "adjudication" would be a matter of comparing test results against predefined functional requirements and expected outputs, often automated or reviewed by a single test engineer or a team.

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. An MRMC study is relevant for imaging devices or diagnostic tools where human interpretation is involved. The Power Express is an automated sample processing system and immunoassay platform; its function is to prepare samples and run assays, not to assist human interpretation of complex data in the way AI assistance might.

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

Yes, the testing described is effectively "standalone" for the automated system. The Power Express system, as an automated sample handling and processing system, operates without direct human intervention in its core tasks (centrifugation, decapping, sorting, routing, pipetting, running assays on connected instruments). The performance data mentioned refers to the verification and validation of this automated system's functionality and software.

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

The "ground truth" for the verification and validation (V&V) described would be the design specifications and functional requirements of the Power Express system. This includes:

• Expected software behaviors and outputs.
• Correct execution of mechanical tasks (e.g., decapping, sorting, pipetting).
• Correct communication protocols with connected instruments and the LIS.
• Adherence to performance metrics like throughput.
• The known performance characteristics of the integrated commercial assays (Ferritin, Folate, hTSH, Vitamin B12) which were previously established and not re-evaluated.

8. The sample size for the training set

Not applicable. The Power Express is an automated sample processing system, not an AI or machine learning model that requires a "training set" of data. The software within the system is likely rule-based or deterministic, rather than learned.

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

Not applicable, as there is no "training set" for this type of device.

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