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The COULTER GEN S System with IRF and MRV Parameters is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER GEN-S System also provides automated Reticulocyte analysis.

An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.

The Immature Reticulocyte Fraction expresses the number of early reticulocytes as a proportion of the total reticulocyte count. Mean reticulocyte volume (MRV) is the average cell volume of the reticulocytes, determined by the VCS Technology algorithm and is reported in femtoliters (fL). This 510(k) Premarket Notification provides information demonstrating that Coulter hematology analyzers with IRF and MRV parameters are substantially equivalent to products previously cleared for this use. The COULTER hematology analyzers with IRF and MRV parameters are compared to Sysmex™ hematology analyzers with the IRF parameter. The MRV parameter is presented as a discussion of the calculation and supported by precision data from a COULTER GEN-S System analyzer. Unlike the Sysmex R-1000, R-3000 and RAM-1 analyzers which are dedicated to the measurement of reticulocyte parameters, the COULTER hematology analyzers, including the GEN.S, measure multiple CBC and differential parameters in addition to the measurement of reticulocyte parameters.

Here's a breakdown of the acceptance criteria and study information for the COULTER® Hematology Analyzers with IRF & MRV Parameters, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a submission for substantial equivalence to predicate devices, rather than a study with pre-defined acceptance criteria for a new device. Therefore, the "acceptance criteria" are implicitly the performance metrics of the predicate devices and the demonstration of equivalent performance by the new device. The study aims to show that the COULTER® device performs comparably to or better than its predicates.

It's important to note that specific numerical "acceptance criteria" for the COULTER device itself are not explicitly stated as pass/fail thresholds in this summary. Instead, the submission relies on demonstrating substantial equivalence to the predicate devices through comparative accuracy and imprecision experiments. The values presented for the COULTER device are its performance measures, which are then compared to the predicate's performance and statistical targets like a mean difference of zero and low standard deviation for imprecision.

Study Information

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

   • IRF Accuracy Analysis (GEN-S vs Sysmex SE9500): N = 332 samples.
   • IRF and MRV Paired Imprecision results (GEN-S): N = 90 samples for each.
   • Data Provenance: Not explicitly stated but usually for such studies, it's clinical samples, likely from the country where the study was conducted (presumably the US, given the FDA submission). It is not specified if the data is retrospective or prospective.

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

   • This is not a diagnostic imaging or classification device where ground truth is established by expert review. For hematology analyzers, the "ground truth" or reference method is typically another established, often manual or highly validated, laboratory method or a predicate device.
   • In this case, for IRF accuracy, the Sysmex SE9500 (predicate device) served as the comparator method against which the COULTER GEN-S's performance was evaluated.

3. Adjudication method for the test set:

   • Not applicable. As described above, this is a comparison against a predicate device, not an expert-adjudicated ground truth.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a study for an automated hematology analyzer, not an AI assistance tool for human readers. Therefore, an MRMC study is not relevant and was not performed.

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

   • Yes, implicitly. The performance data presented (IRF accuracy and IRF/MRV imprecision) are for the COULTER® Hematology Analyzers as automated, standalone devices. They are designed to provide quantitative measurements without human intervention in the primary measurement and calculation process. The comparison is between two automated systems.

6. The type of ground truth used:

   • For IRF Accuracy, the ground truth was the predicate device's measurement (Sysmex SE9500). This is a common approach in demonstrating substantial equivalence for new IVD devices by comparing them to an already legally marketed and validated device.
   • For IRF and MRV Imprecision, the ground truth is internal consistency and reproducibility of the device itself over repeated measurements, rather than an external gold standard.

7. The sample size for the training set:

   • Not specified. The document primarily focuses on the validation of the device for regulatory submission, presenting performance data (test set results). Information about the training set size (if any, for internal algorithm development) is not typically included in such summaries.

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

   • Not specified. Similar to the training set size, the specifics of how internal algorithm development and potential training data ground truth were established are not part of this regulatory summary.

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The COULTER® Z2 instrument may be used for in vitro diagnostic use to determine the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Plt). In addition, the COULTER Z2 also provides the mean erythrocyte volume (Mean Cell Volume or MCV) and the mean thrombocyte volume (Mean Platelet Volume or MPV).

The COULTER Z2 is a general purpose dual threshold particle counter and sizer designed to count and size particles, suspended in an aqueous electrolyte solution, within the range of 1 to 120 um equivalent spherical diameter. The instrument is designed for both biological and industrial use. As with the predicate devices, the COULTER Z2 utilizes the Coulter principle for the enumeration and sizing of blood cells. The same reagent system, composed of an isotonic diluent, lytic reagent to lyse red blood cells for WBC measurement and instrument cleaner, is used on COULTER STKS, Z1, and Z2 instruments. The COULTER STKS, Z1, and Z2 instruments are capable of determining the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Plt). In addition, like the COULTER STKS, the COULTER Z2 also provides the mean erythrocyte volume (Mean Cell Volume or MCV) and the mean thrombocyte volume (Mean Platelet Volume or MPV). Both the COULTER Z1 and the Z2 instruments contain a hydraulic metering station built into the electronics main unit, measure a restricted range of particle sizes (within the range 1 to 120 µM) and utilize surface-mount technology. Operator-adjustable controls are accessible by means of a keyboard data terminal.

Here's a breakdown of the acceptance criteria and study information for the COULTER® Z2 Analyzer, based on the provided text:

Acceptance Criteria and Device Performance for COULTER® Z2 Analyzer

The provided document describes the COULTER® Z2 Analyzer and its substantial equivalence to predicate devices, focusing on the added parameters of Mean Cell Volume (MCV) and Mean Platelet Volume (MPV). The "acceptance criteria" are implicitly defined by the reported performance metrics (imprecision and accuracy) that demonstrate its equivalence to already commercially distributed hematology analyzers.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit "acceptance criteria" are not given in numerical ranges (e.g., "CV% must be

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The reticONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems combines a reagent kit consisting of a Coriphosphine-O dye and a Biological Calibrator, and software for automated analysis of reticulocytes in whole blood using EPICS® XL™ Flow Cytometry Systems with SYSTEM II™ Software. The system is intended "For In Vitro Diagnostic Use" and allows identification and enumeration of reticulocyte percentage and absolute count.

The reticulocyte count is diagnostically useful in discriminating between normal erythropoiesis. It can be useful in the diagnosis or detection of anemal hemorthaging, hemoglobinopathies and certain nutritional or vitamin deficiencies. Decreased or defective red cell production may result in a lower reticulocyte count such as in aplastic anemias. Elevated reticulocyte counts may be observed in clinical conditions where red cell destruction is increased (for example, hemolytic anemias and hypersplenism) or where there is increased red cell production (for example, erythropoietin drug therapy and a response to treated anemia).

Since the kidneys are a primary source of erythropoietin (a hormone that regulates erythroid development), the reticulosyte count is also affected in individuals with renal disease. In cases of renal atrophy, the reticulocyte count will be decreased. In cases of malignancy or hypersplenism, the reticulocyte count will be elevated.

Reticulocyte counts are also used as an indicator of bone marrow recovery following intensive or a bone marrow transplantation. Increased reticulocyte counts in these patients are indicative of bone marrow regeneration.

The reticONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems combines a reagent kit consisting of a Coriphosphine-O dye and a Biological Calibrator, and software for automated analysis of reticulocytes in whole blood using EPICS® XL™ Flow Cytometry Systems with SYSTEM II™ Software. The system is intended "For In Vitro Diagnostic Use" and allows identification and enumeration of reticulocyte percentage and absolute count.

The reticONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems has demonstrated its performance through a series of studies. The acceptance criteria and device performance are outlined below, along with details regarding the study methodologies.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Stability Studies (1.a): 3 normal whole blood specimens. These were likely prospective as they involved specific handling and analysis over defined time points. The country of origin for these specimens is not explicitly stated but can be inferred as the USA, given the company's location and FDA submission.
• Stability Studies (1.b): 10 normal whole blood specimens. Similar to above, likely prospective and from the USA.
• Stability Studies (1.c): 5 normal whole blood specimens. Similar to above, likely prospective and from the USA.
• Carryover Study (2): Not explicitly stated as "specimens" but "a single sample" was prepared for each of the High Level and Low Level Retic-Chex control products. These are commercial control products, not patient specimens.
• Linearity Study (3): 2 whole blood specimens, serially diluted to create 10 data points. Likely prospective and from the USA.
• Precision Study (4.a, 4.c): "Sample [normal or abnormal] whole blood specimens" for each of five levels of reticulocyte percentage. The exact number of specimens is not specified beyond "for each of five levels."
• Precision Study (4.b): Samples from a single normal whole blood specimen.
• Accuracy Study (5): "Normal and abnormal whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 18 to 85 years." The exact number of specimens is not specified. The provenance is described as "geographically diverse populations," implying a broader reach, but still likely within the USA given the submission context. These were likely prospective as they involved parallel processing and assaying with two systems.

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

The ground truth in these studies is primarily established by a predicate device (Retic-COUNT™) and established laboratory methods and controls (e.g., NCCLS Document H44-A). No human experts are explicitly mentioned as establishing a "ground truth" for individual cases in the way that, for example, a radiologist would interpret an image. The performance of the reticONE™ SYSTEM is compared against the established performance of the predicate device and expected biological/analytical behavior.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is primarily based on comparison to a predicate device or established analytical control materials/standards, not on human interpretation that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. The studies focused on the analytical performance of the device itself (stability, linearity, precision, carryover) and its concordance with a predicate device, not on how human readers' performance might improve with or without AI assistance. This device is an automated reticulocyte analysis system, replacing manual microscopy, rather than an AI-assisted diagnostic tool for human interpretation.

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

Yes, the studies conducted demonstrate the standalone performance of the reticONE™ SYSTEM. The system is described as combining "a reagent kit...and software for automated analysis of reticulocytes." The performance metrics reported (stability, linearity, precision, accuracy) are inherent to the automated system and its reagents/software. There is no mention of a human-in-the-loop component for the analysis process itself as part of these performance studies.

7. The Type of Ground Truth Used

The primary type of "ground truth" used is:

• Predicate Device Performance: The Retic-COUNT™ system (K872166 and K880636) served as the reference for accuracy, with the reticONE™ SYSTEM demonstrating comparable results.
• Established Analytical Methods/Controls: The studies refer to NCCLS Document H44-A for procedures like carryover testing. Commercial control products (e.g., Streck Laboratories, Inc® multiple-level Reticulocyte Control product, Retic-Chex) were also used.
• Expected Physiological/Analytical Behavior: For linearity, serial dilutions were used to achieve a "defined range of expected reticulocytes." Stability was assessed against the expectation that measurements would not significantly change over time under specified conditions.

8. The Sample Size for the Training Set

No explicit training set is mentioned in the provided document. As a medical device that automates a laboratory assay rather than a machine learning model that needs to be "trained" on data, the concept of a training set as understood in AI/ML is not directly applicable here. The system's "training" would be more akin to software development and calibration during its design and manufacturing.

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

Not applicable, as no training set (in the AI/ML sense) is described. The system's underlying principles are based on established flow cytometry technology, fluorescent staining, and standard hematological analysis.

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The tetraONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems with CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent combine four-color fluorescent monoclonal antibody reagents, quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood using EPICS® XL™ flow cytometry systems with SYSTEM II™ Software. The system is intended "For In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+, CD19+, and CD3-/CD56+ lymphocyte population percentages and absolute counts. The system also provides the T4/T8 ratio when using CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent, and total lymphocyte percentage when using CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent.

CD3+, CD4+, CD8+, and/or CD19+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocyte levels following organ transplantation.

To illustrate, identification of abnormal levels of CD3+, CD4+, CD8+, and/or CD19+ lymphocytes may aid in the diagnosis and/or prognosis of unidentified disease conditions in patients with altered white blood cell counts. Altered percentages of CD3+, CD4+, CD8+, and/or CD19+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T (CD3+, CD4+, CD8+) and/or B (CD19+) lymphocyte measurements may be useful as aids in monitoring these cellular populations.

Identification of abnormal levels of CD4+ immunodeficiency might also aid in the diagnosis of immunodeficiency disease. For example, infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS), results in profound immunosuppression due predominantly to a selective of the CD4+ lymphocytes that express the receptor for the virus, which is associated with the CD4+ antigen. Progressive clinical and immunologic deterioration generally correlated with a falling CD4+ lymphocyte count.

NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytotoxicity against targets such as certain tumor and virus-infected cells.

CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. Used as a four color Lymphocyte Immunophenotyping Panel, CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 also function as a quality control check for a specimen in terms of CD3+ lymphocyte measurement reproducibility within the Panel.

The tetraONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems with CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent combine four-color fluorescent monoclonal antibody reagents, quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood using EPICS® XL™ flow cytometry systems with SYSTEM II™ Software.

Here's a breakdown of the acceptance criteria and study information for the tetraONE™ SYSTEM, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance specifications for the CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 reagent within the tetraONE™ SYSTEM. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient, maximum CV) are not quantified directly in the provided text as a specific table of acceptance criteria, the study design and results implicitly indicate the performance levels deemed acceptable for each tested parameter.

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

• Test Set Sample Size:
  • Accuracy: "Normal and abnormal whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 18 to 84 years." The specific number of specimens is not provided in the text.
  • Linearity: Not specified, but involved a "concentrated COULTER™ CYTO-TROL™ Control Cells sample serially diluted" to achieve a range of concentrations.
  • Precision (Within Run): "Ten replicate measurements were made for each of three levels of CD3+, CD19+ and CD3-/CD56+ lymphocyte concentrations." The number of individual patient samples used to create these 'levels' is not specified.
  • Precision (Interlaboratory): "Ten replicate measurements were made on the same day using different laboratories... All measurements were made on a single normal whole blood specimen". The number of laboratories is not specified.
• Data Provenance: The specimens for the Accuracy study were "collected from geographically diverse populations." This suggests it was retrospective for the purpose of the study (pre-collected as "specimens") and likely from the USA given the company and regulatory body location, though "geographically diverse" could imply wider sourcing. Linearity and Precision studies used control cells or single normal whole blood specimens, which are laboratory-prepared or sourced.

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

• Not Applicable. This device is a diagnostic reagent system for flow cytometry, not an AI or imaging device that requires human expert interpretation for ground truth. The "ground truth" for this type of device is established by the performance of the predicate device and objective measures like cell counts, percentages, and statistical comparisons, rather than expert consensus on interpretive tasks.

4. Adjudication Method (for the test set)

• Not Applicable. As mentioned above, this study does not involve subjective interpretations requiring adjudication. Performance is assessed through statistical analysis against predicate devices and known analytical characteristics (linearity, precision).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is not relevant for this type of in vitro diagnostic device, which evaluates the analytical performance of a reagent system rather than human reader accuracy with or without AI assistance.

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

• Yes, effectively. The entire study described assesses the performance of the tetraONE™ SYSTEM (reagents and software for automated analysis) in a standalone analytical context. Human involvement is in operating the flow cytometer and processing samples, but the "performance" being evaluated is that of the system itself in identifying and enumerating cell populations, not a human interpretation task. The results (cell counts, percentages) are direct outputs of the system, compared against predicate systems.

7. The Type of Ground Truth Used

• The ground truth used is effectively predicate device performance and analytical correctness (e.g., expected values from diluted control cells, consistency in replicate measurements). For accuracy, the new device's results (CD45/CD56/CD19/CD3) were compared against established predicate devices (CD3/B4 and CD3/CD56) which are presumably considered the "gold standard" or accepted method for enumerating these lymphocyte populations. For linearity and precision, the ground truth is the expected performance based on known dilutions or statistical characteristics of repeated measurements.

8. The Sample Size for the Training Set

• Not Applicable/Not Specified. This document describes the validation of an in vitro diagnostic reagent and software system, not an AI model that undergoes a distinct "training" phase with a large dataset in the conventional machine learning sense. The software's algorithms for automated analysis are likely based on established flow cytometry principles and, while potentially "developed" using data, the document does not refer to a specific "training set" in the context of deep learning or similar AI models.

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

• Not Applicable. (See point 8). The "ground truth" for the development of such an IVD system's algorithms would typically be based on established immunological principles, manual gating by expert flow cytometrists, and historical data from previous generations of flow cytometry systems, rather than a separate, explicitly defined "training set ground truth" as understood in modern AI development.

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The COULTER® AC T diff 2m analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.

An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.

The COULTER® Ac·T diff 2™ Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. COULTER® Ac.T diff 2™ Analyzer has the same technological characteristics and is substantially equivalent to the COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D (also called COULTER COUNTER® Model S PLUS IV with Three Population Differential and Model S PLUS IV Diff), which was cleared by 510(k) K823355 on Dec. 28, 1982 and is a modified version of the COULTER® Ac-T diff ™ Analyzer which were cleared by 510(k) K973634 on October 29, 1997.

As with the predicate devices, the COULTER® Ac-T diff 2™ Analyzer utilizes the Coulter principle for the enumeration and sizing of blood cells, in combination with an automatic diluting and mixing device for sample processing and a single beam photometer for the measurement of hemoglobin. The same reagent system, composed of an isotonic diluent, lyitc reagent to lyse red blood cells for WBC and hemoglobin measurement and instrument cleaner, is used on Model S PLUS IV Diff and Ac-T diff Analyzers.

All the devices determine the following CBC parameters: WBC, LY #, LY%, MO #, MO %, GR #, GR %, RBC, Hgb, Hct, MCV, MCH, MCHC, Plt, RDW, MPV. Pct* and PDW* are also measured. *These parameters are not for diagnostic use but can be used as internal instrument checks on the platelet parameters.

Like the Ac T diff Analyzer, the Ac T diff 2 can analyze samples in either of two modes: whole blood and pre-dilute. Additionally, the Ac-T diff 2 can sample closed vial specimens by virtue of a rotary cap piercing functionality. The MODEL S PLUS IV Diff does not have a pre-dilute mode or a closed vial sampling mode.

This document is primarily a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the requested information, particularly regarding acceptance criteria, a study proving the device meets the criteria, sample sizes for test sets and training sets, expert qualifications, and ground truth adjudication, is not explicitly provided in the given text.

The document describes the device, its intended use, and compares its technological characteristics to predicate devices. It states that the device "has the same technological characteristics" and is "substantially equivalent" to the predicate. This implies that the performance characteristics are expected to be similar, but it doesn't detail a specific acceptance criteria study for this new device.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the COULTER® Ac·T diff 2™ Analyzer. Instead, it outlines the parameters measured by the device and asserts its substantial equivalence to predicate devices, implying that its performance is comparable to those already cleared devices.

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

The document does not provide details about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for the Ac-T diff 2 device. The submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo performance study with a new dataset.

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 document. As a 510(k) submission, the focus is on technological similarity to existing devices, not on a new clinical study requiring independent expert ground truth establishment for novel algorithms.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No MRMC study is mentioned or implied. The device is an automated hematology analyzer, not a diagnostic imaging AI system that typically involves human readers.

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

The device itself is a standalone automated hematology analyzer. Its performance is inherent to its operation as described, without human intervention in the analysis process (though human interpretation of results is part of clinical use). However, the document does not present a specific standalone study for the Ac-T diff 2 device; it focuses on its substantial equivalence to prior predicate devices.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any specific performance study of the Ac-T diff 2. Given it's a hematology analyzer, "ground truth" for its parameters (e.g., cell counts, hemoglobin) would typically be established through reference methods, manual microscopy, or highly characterized control materials, which are standard for predicate devices of this type. The Ac-T diff 2 is presented as technically equivalent to these established devices.

8. Sample Size for the Training Set

No training set or associated sample size is mentioned. This device is a traditional automated analyzer based on physical principles (Coulter principle, photometry), not a machine learning or AI algorithm that typically has a "training set."

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

Not applicable, as no training set for a machine learning model is mentioned.

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IMMUNO-TROL™ Control Cells (Immuno-Trol) is an for an assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytomerry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of reagent performance and the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by flow cytometry. CD populations intended "For In Vitro Diagnostic Use" and those intended "For Research Use In Diagnostic Procedures." are given in separate tables in the TABLE OF EXPECTED RESULTS section of the Immuno-Trol package insert.

Immunophenotyping analysis by flow cytometry involves the identification and enumeration of targeted cells in whole blood samples. Whole blood samples are stained with monoclonal antibodies and erythrocytes are lysed prior to flow cytometric analysis. A positive cell control is required to verify reagent performance, sample performance, sample preparation methods, and staining procedures. A positive cell control should mimic a representative whole blood sample in terms of monoclonal antibody performance, erythrocyte lysing, and flow cytometric analysis.

IMMUNO-TROL™ Control Cells (Immuno-Trol) is an assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample.

The IMMUNO-TROL™ Control Cells device is a quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It is intended to provide a positive cell control that mimics a whole blood sample to verify reagent performance, sample preparation methods, and staining procedures.

Here's a breakdown of the acceptance criteria and supporting study details:

1. Acceptance Criteria and Reported Device Performance

The general acceptance criterion across all studies was that "all values met the Acceptance Criteria." While specific numerical performance targets (e.g., specific ranges for percent positive or absolute counts) are not explicitly stated in this document for each individual parameter, the document consistently indicates successful performance against these internal criteria. The comparison to predicate devices (Normal Whole Blood (NWB) and CYTO-TROL™ Control Cells Kit (CYTO-TROL)) served as an implicit benchmark for acceptable performance.

Study Details

The provided document describes various studies conducted to assess the performance of IMMUNO-TROL™ Control Cells.

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

• Vial-to-Vial Reproducibility: "The filled vials were sampled from Immuno-Trol lots at regular intervals across the fill." (Specific number of vials/samples, country of origin, and whether retrospective/prospective are not explicitly provided. However, the description implies prospective testing of manufactured lots.)
• Lot-to-Lot Reproducibility: "Testing produced overall percent positive (%) and absolute count (as applicable) results for the leukocyte surface antigens given in the Immuno-Trol Package Insert." (Specific number of lots, different instrument-operator combinations, country of origin, and whether retrospective/prospective are not explicitly provided. Implies prospective testing.)
• Stability Studies: Two study protocols were used: "Closed Vial: 90 days at 2-8℃; Open Vial: 30 days at 2-8℃" and "Stored Prepared Sample: 2 hours at 20-25°C; 24 hours at 2-8°C." "Immuno-Trol was tested using one-color, threecolor and four-color monoclonal antibody reagents under the different storage and temperature conditions over test periods extending up to and beyond the respective 90-day and 30-day claims." (Specific number of samples/lots, country of origin, and whether retrospective/prospective are not explicitly provided. Implies prospective testing over time.)
• Absolute Count Method Verification: "Immuno-Trol" and "NWB was also tested under the same conditions." (Specific number of samples and country of origin are not explicitly provided. Implies prospective testing.)
• Assay Precision: "Immuno-Trol on different instrument-operator combinations and over multiple test days using one-color and four-color and four-color monoclonal antibody reagents. NWB and CYTO-TROL were also tested under the same conditions." (Specific number of samples, test days, country of origin, and whether retrospective/prospective are not explicitly provided. Implies prospective testing.)

Overall Data Provenance: The company, Coulter Corporation, is based in Miami, Florida, USA. Therefore, it is highly likely the data provenance is USA. The studies are described as "Product testing to assess the performance," implying they are prospective studies conducted by the manufacturer for regulatory submission.

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

The concept of "ground truth" as typically applied to AI/diagnostic imaging (e.g., expert consensus) is not applicable here. This document describes the performance of a quality control material intended to verify the performance of other diagnostic reagents and methods, not to provide a diagnosis itself. The "ground truth" for this device is its inherent, manufactured cellular composition and expected reactivity with specific antibody reagents, which are compared against established performance specifications.

4. Adjudication Method for the Test Set

Not applicable. As this is a performance study for a quality control material, not a clinical diagnostic device requiring expert interpretation of results, there is no adjudication method in the traditional sense (e.g., 2+1, 3+1). The "ground truth" is defined by the product's design and manufacturing specifications.

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

No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or algorithms where human readers interpret cases. The IMMUNO-TROL device is a quality control material.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. The IMMUNO-TROL is a physical control cell product, not an algorithm. Its performance is intrinsically linked to its use with flow cytometry instruments and monoclonal antibody reagents.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation of IMMUNO-TROL is based on established manufacturing specifications and expected reactivity of the control cells with monoclonal antibody reagents for immunophenotyping. This constitutes an analytical truth rather than a clinical ground truth like pathology or outcome data. The "Acceptance Criteria" mentioned throughout the document are derived from these internal specifications. The predicate devices (NWB and CYTO-TROL) also served as a comparative benchmark to ensure comparable performance.

8. Sample Size for the Training Set

Not applicable. The IMMUNO-TROL is not an artificial intelligence or machine learning device that requires a "training set." It is a manufactured quality control product.

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

Not applicable. As there is no training set for this product.

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CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification of total CD3+ and CD19+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITCMsIgG1-PCS, is used to monitor nonspecific staining.

CYTO-STAT® triCHROME™ CD45-FITCMsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two MsIgG1 subclass monoclonal antibodies conjugated to RD1 and PC5.

CD3+ and/or CD19+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocyte levels following organ transplantation.

To illustrate, identification of abnormal levels of CD3+ lymphocytes may aid in the diagnosis and/or prognosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ and/or CD19+ lymphocytes, in conjunction with CD4+ (inducer) and CD8+ (suppressor/cytotoxic) T lymphocytes and corresponding T4/T8 ratios, may aid in the diagnosis and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, hear, liver, lung) transplantation suggests T and/or B Jymphocyte quantitation may be useful as an aid in monitoring these cellular populations.

As part of a Three Color Lymphocyte Immunophenotyping Panel which includes the NK (Natural Killer) lymphocyte reagent, CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PCS, CYTO-STAT® triCHROME™ CD45-FITC/CD19-RDI/CD3-PC5 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T. B and NK. The reagent also functions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.

CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD19+ lymphocytes in whole blood by flow cytometry. An isotypic control. CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-RD1/MsIgG1-PC5, is used to monitor nonspecific staining.

CYTO-STAT® triCHROME CD45-FITC/MsIgG1-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two monoclonal antibodies of the MsIgG1 subclass conjugated to RD1 and PC5.

The provided text describes the performance testing for the CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent. The objective of the study was to demonstrate that this new reagent meets performance specifications and provides comparable results to a predicate device, CD3/B4.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria (e.g., specific percentage agreement or correlation coefficients that must be met). Instead, it describes the types of performance that were evaluated and the conclusion that the device met these specifications.

2. Sample Size and Data Provenance

• Test Set Sample Size: For the Accuracy study, "Normal and abnormal whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 19 to 84 years." The exact number of specimens is not specified in the provided text.
• Data Provenance: The data is prospective, as specimens were collected specifically for this testing. The geographic diversity implies the data is likely from the USA (where Coulter Corporation is headquartered).

3. Number of Experts and Qualifications for Ground Truth

This type of device (monoclonal antibody reagent for flow cytometry) does not typically involve human expert adjudication for establishing ground truth in the same way an imaging device might. The "ground truth" for the comparative effectiveness aspect is the performance of the predicate device (CD3/B4). For linearity and precision studies, the "ground truth" is derived from the expected values based on dilutions or control samples, measured by the flow cytometer itself, without human expert interpretation.

Therefore:

• Number of experts: Not applicable in the context of human interpretation of results.
• Qualifications of experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable, as the evaluation involves flow cytometry measurements against a predicate device's results and analytical performance metrics, not human adjudication of discrete findings.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is more relevant for diagnostic imaging devices where multiple human readers interpret cases. The reported study compares the performance of the new reagent to a predicate reagent using flow cytometry measurements, not human interpretation.

6. Standalone Performance Study

Yes, a standalone performance study was performed in several ways:

• Linearity: The linearity study assesses the algorithm's (flow cytometer's) ability to accurately measure concentrations across a range without comparison to a human reader.
• Precision (Intralaboratory and Interlaboratory): These studies evaluate the consistency and reproducibility of the device's measurements in isolation (though compared across labs for interlaboratory precision).
• While the accuracy study compares to a predicate, the fundamental measurements (CD3+, CD19+ percentages and absolute counts) are generated by the algorithm/device in a standalone fashion. The comparison is between two device-generated outputs.

7. Type of Ground Truth Used

The primary "ground truth" used for Accuracy was the predicate device's performance (CD3/B4) for identifying and enumerating CD3+ and CD19+ lymphocytes. For Linearity, it was the expected absolute counts from serially diluted samples. For Precision, it was the mean and standard deviation of replicate measurements indicating the device's inherent variability.

8. Sample Size for the Training Set

The document does not mention a training set. This product is a reagent for flow cytometry, not an algorithm that requires machine learning training data. The "training" of the system would involve calibration and setup of the flow cytometer itself, not a specific dataset for the reagent.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for a machine learning algorithm.

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CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-PC5, is used to monitor nonspecific staining.

CYTO-STAT® triCHROME™ CD45-FITCMsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluoresent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two MsIgG1 subclass monoclonal antibodies conjugated to RD1 and PC5.

CD3+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocvte levels following organ transplantation.

To illustrate, identification of abnormal levels of CD3+ lymphocytes may aid in the diagnosis and/or progrosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ lymphocytes, in conjunction with CD4+ (induce) and CD8+ (suppressor/cytoxic) T lymphocytes and corresponding T478 ratios, may aid in the diagnois and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T lymphocyte quantitation may be useful as an aid in monitoring these cellular populations.

NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytoxicity against targets such as certain tumor and virus-infected cells.

As part of a Three Color Lymphocyte Immunophenotyping Panel which includes the B lymphocyte reagent, CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5, CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. The reagent also functions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.

CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-.

CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two monoclonal antibodies conjugated to RD1 and PC5.

This document describes the safety and effectiveness information for the NOV COULTER CORPORATION's CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent with its corresponding Isotypic Control. The information provided focuses on the product's performance specifications and how it meets them.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "performance specifications" that the device is stated to meet. The study's results demonstrated that the device successfully met these specifications.

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

• Sample Size: The document states that "Normal and abnormal whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 19 to 84 years." However, the exact number of specimens/samples used for the accuracy, linearity, and precision studies is not explicitly stated. For the within-run precision, "Ten replicate measurements were made for each of three levels of CD3+ and CD3-/CD56+ lymphocyte concentrations." For interlaboratory precision, "Ten replicate measurements on were made on the same day."
• Data Provenance: The specimens were collected from "geographically diverse populations." The document does not specify particular countries but implies a broad collection. The study appears to be prospective in nature, as specimens were "collected" and then "processed as lysed preparations and assayed in parallel" for the purpose of this product testing.

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

This type of device (monoclonal antibody reagent for flow cytometry) relies on established cellular markers and flow cytometry principles rather than subjective expert interpretation for ground truth. Therefore, there's no mention of "experts" in the traditional sense of adjudicating images or clinical cases. The "ground truth" is inherently tied to the established scientific understanding of CD antigens and their detection via flow cytometry. The reference device, CYTO-STAT® CD3/CD56, serves as the comparison for establishing equivalence, implying its performance is considered the de facto "truth" against which the new device is measured.

4. Adjudication Method for the Test Set

Not applicable for this type of in vitro diagnostic device study. The "ground truth" is determined by the measurements obtained from the predicate device and the consistent application of flow cytometry principles. The performance of the new device is directly compared to these measurements.

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. This is an in vitro diagnostic reagent, not an AI-assisted diagnostic tool that involves human readers interpreting results.

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

Not applicable. This is a reagent for flow cytometry, not an algorithm. The "performance" is the ability of the reagent to accurately label cells for subsequent analysis by a flow cytometer, which produces quantitative data. Human operators are involved in specimen preparation, running the flow cytometer, and interpreting the raw flow cytometry data (e.g., gating lymphocytes), but the reagent itself is not a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth used is comparison to a legally marketed predicate device (CYTO-STAT® CD3-FITC/CD56-RD1 Monoclonal Antibody Reagent with CYTO-STAT®/COULTER CLONE® MsIgG1-RD1/MsIgG1-FITC Isotypic Control). The performance of the new device (CD45/CD56/CD3) was compared to this predicate device (CD3/CD56) using flow cytometry measurements, which are considered quantitative and objective measures for cell populations.

8. The Sample Size for the Training Set

Not applicable. This is a reagent, not an AI model that requires a training set. The development of the reagent involves chemical and biological formulation, not data training.

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

Not applicable, as there is no training set for a reagent product.

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CYTO-STAT® CD3-FITC/CD56-RD1 Monoclonal Antibody Reagent is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-/CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT®/COULTER CLONE® MslgG1-RD1/MsIgG1-FITC, is used to monitor nonspecific staining.

CYTO-STAT®COULTER CLONE® MsIgG1-RD1/MsJgG1-PC5 Isotypic Control is a two-color fluorescent reagent comprised of two murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® or CYTO-STAT®/COULTER CLONE® Monoclonal Antibody Reagents comprised of two MsIgGl subclass monoclonal antibodies conjugated to RD1 and FITC.

CD3+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocyte levels following organ transplantation.

To illustrate, identification of abnormal levels of CD3+ lymphocytes may aid in the diagnosis and/or prognosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ lymphocytes, in conjunction with CD4+ (inducer) and CD8+ (suppressor/cytotoxic) T lymphocytes and corresponding T4T8 ratios, may aid in the diagnosis and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T lymphocyte quantitation may be useful as an aid in monitoring these cellular populations.

NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytoxicity against targets such as certain tumor and virus-infected cells.

As part of a Two Color Lymphocyte Immunophenotyping Panel which includes the B lymphocyte reagent, CYTO-STAT®/COULTER® CLONE® CD3(IgG1)-FITC/B4-RD1, CYTO-STAT® CD3-FITC/CD56-RD1 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. The reagent also finctions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.

CYTO-STAT® CD3-FITC/CD56-RD1 is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-/CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT®/COULTER® CLONE® MsIgG1-RD1/MsIgG1-FITC, is used to monitor nonspecific staining.

CYTO-STAT®/COULTER® CLONE® MsIgG1-RD1/MsIgG1-FITC is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® OR CYTO-STAT®/COULTER® CLONE® Monoclonal Antibody Reagents comprised of two monoclonal antibodies of the MsIgG1 subclass conjugated to RD1 and FITC.

Acceptance Criteria and Study for CYTO-STAT® CD3-FITC/CD56-RD1 Monoclonal Antibody Reagent

This response describes the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Accuracy Study:
  • Sample Size: Not explicitly stated as a number, but "Normal and abnormal whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 19 to 84 years."
  • Data Provenance: Prospective collection from "geographically diverse populations" (country of origin not specifically mentioned, but the manufacturer is based in Miami, Florida, USA, and has international affiliates, suggesting a potential for multi-country data, though not confirmed). The data appears to be prospective as specimens were "collected" and "processed as lysed preparations and assayed in parallel."
• Linearity Study:
  • Sample Size: A "concentrated COULTER™ CYTO-TROL Cells sample serially diluted to achieve a range of CD3+ and CD3-/CD56+ lymphocyte concentrations." The number of dilutions or individual measurements is not specified beyond "Three replicate measurements."
  • Data Provenance: Not explicitly stated, but likely laboratory-generated data using a control sample.
• Precision (Within Run) Study:
  • Sample Size: "Ten replicate measurements" for each of CD3+ and CD3-/CD56+ lymphocyte concentrations. The levels were obtained by "selective screening of normal whole blood specimens."
  • Data Provenance: Not explicitly stated, but likely laboratory-generated data.
• Precision (Interlaboratory) Study:
  • Sample Size: "Ten replicate measurements" on "a single normal whole blood specimen" across "different laboratories."
  • Data Provenance: Not explicitly stated, but data from multiple laboratories testing the same specimen.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be based on comparative performance with a legally marketed predicate device (CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/B4-RD1) and established methods (flow cytometry and white blood cell counts/5-part differentials).

4. Adjudication Method for the Test Set

No adjudication method is described or implied in the provided text. The evaluation seems to be based on statistical analyses of the obtained measurements against those from the predicate device and expected biological ranges.

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

No MRMC comparative effectiveness study was mentioned. This device is a reagent used in flow cytometry, not an AI-assisted diagnostic tool that would involve human "readers" or AI for image interpretation.

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

This is not applicable as the device is a reagent for flow cytometry, not an algorithm. The "performance" described is of the reagent's ability to accurately identify and enumerate cell populations when used with a flow cytometer.

7. The Type of Ground Truth Used

The ground truth for the assessment of the new device (CD3/CD56) was established by comparison to:

• A legally marketed predicate device: "Specimens were assayed with CD3/B4 for comparison purposes." The predicate device is identified as CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/B4-RD1.
• Established clinical methods: "White blood cell counts and 5-part differentials were obtained for all specimens."
• Biological expectations: The goal was to identify and enumerate "appropriate numbers" of targeted lymphocytes.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. This device is a reagent, and its development would typically involve optimization and validation rather than training in the AI sense.

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

Not applicable, as there is no mention of a training set for an algorithm in this context. The development process would have involved establishing the optimal antibody concentrations and fluorochrome conjugates for accurate and specific binding.

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The COULTER® AC-T diff™ analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.

The product is a hematology Automated Differential Cell Counter which like the predicate devices, COULTER A C T Series Analyzer and COULTER COUNTER S-PLUS IV and LYSE S PLUS D, uses the Coulter method of impedance measurement for particle counting and sizing. Blood cells passing through a small opening simultaneously with an electric current cause an impedance change in the orifice. This electrical pulse can be sized and counted. While the number of pulses indicates the particle count, the size of the electrical pulse is proportional to cell volume. Under the controlled condition of lysis, a chemical reaction demonstrates three distinct populations of leukocytes: lymphocytes, mononuclear cells and granulocytes. The percentage of leukocytes that fall into each of the three categories is derived from the WBC histogram: the LY area is approximately from 35 fL to 90 fL, the MO area is approximately from 90 fL to 160 fL and the GR area is approximately from 160 fL. The COULTER® AC T diff™ Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER® AC T diff analyzer has the same intended use as the predicate devices. Both the A.T diff and the predicate devices utilize the Coulter principle for cell counting and sizing in combination with automatic diluting and mixing for sample processing and a beam photometer for hemoglobinometry. The same reagent system, consisting of isotonic diluent, lytic reagent, and cleaning agent, is used on the AS.T diff analyzers and the predicate devices. The ACT diff analyzers and the predicate devices have the ability to print and transmit results if the instrument has been setup to do so. The COULTER AC T diff Analyzer is the same device as the COULTER AS T Series Analyzers except for the modifications required for the measurement of a three-part leukocyte differential, RDW, and MPV, automated calibration and quality control evaluation, patient storage and selectable print profiles.

The provided text describes the COULTER® AC·T diff™ Analyzer, a hematology automated differential cell counter. However, it does not include a detailed study proving the device meets specific acceptance criteria.

The submission states: "Testing described in Section 2 of this submission focuses on attributes of precision and accuracy for the additional parameters (i. e. WBC differential, RDW and MPV). Testing met all acceptance criteria." However, "Section 2" and the actual test results or acceptance criteria themselves are not provided in the input text.

Therefore, the following information is based on the available text, with limitations noted for what is not present.

Acceptance Criteria and Device Performance Study Details (Based on Available Information):

Limitations: The provided document is a 510(k) summary (K973634) and an FDA clearance letter. It does not contain the detailed study report, specific acceptance criteria values, or reported performance metrics. It only states that "Testing met all acceptance criteria" for precision and accuracy of WBC differential, RDW, and MPV.

1. Table of Acceptance Criteria and Reported Device Performance:

   Note: The specific acceptance criteria values and reported performance metrics are not provided in the given text. The text only states that testing met these criteria for the parameters listed below.

   Parameter	Acceptance Criteria	Reported Device Performance
   WBC Differential (Lymphocytes, Monocytes, Granulocytes)	(Specific criteria for precision and accuracy not provided in this document)	"Testing met all acceptance criteria" for precision and accuracy.
   Red Cell Distribution Width (RDW)	(Specific criteria for precision and accuracy not provided in this document)	"Testing met all acceptance criteria" for precision and accuracy.
   Mean Platelet Volume (MPV)	(Specific criteria for precision and accuracy not provided in this document)	"Testing met all acceptance criteria" for precision and accuracy.

Further Study Details (Based on Available Information):

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

   • Test Set Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

   • This information is not provided as the ground truth determination method is not detailed. For a differential cell counter, this would typically involve trained laboratory technologists performing manual differential counts, potentially reviewed by pathologists.

4. Adjudication method for the test set:

   • Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is an automated hematology analyzer, not an AI-assisted diagnostic tool for human readers in the context of image interpretation. It performs automated cell counting and differentiation.

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

   • Yes, implicitly. Automated hematology analyzers operate in a standalone manner to count and differentiate cells. The "testing" mentioned for precision and accuracy likely refers to the performance of the device's algorithms and internal measurement systems without human intervention during the measurement process. Human intervention would occur in sample preparation, loading, and result review.

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

   • Not explicitly stated, but for hematology analyzers, the reference method for confirming accuracy of automated differential counts is typically manual microscopic differential count performed by trained technologists, which can be considered a form of "expert consensus" or "gold standard" in hematology.

8. The sample size for the training set:

   • Not applicable / Not specified. Automated hematology analyzers from this era (1997) typically rely on pre-programmed algorithms based on physical principles (impedance) and defined cell size ranges, rather than machine learning models that require explicit training sets in the modern sense. The "training" would involve extensive engineering, calibration, and validation against known samples to establish the correct parameters for cell differentiation.

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

   • Not applicable / Not specified. As explained above, the device likely relies on established physical principles and pre-defined parameters rather than a machine learning training set with ground truth labels. If any "calibration" or parameter optimization was done against known samples, the ground truth would have been established through a reference method like manual differential counts.

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