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CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument.

CD4 Count is a suspension of stabilized human blood packaged in a plastic vial OD4 Obant 16 a cuppinelon the vials are packaged in a vacuum formed "clam-shell" box.

The provided text describes a 510(k) summary for the device "CD4 Count," an immunophenotyping control. The studies conducted primarily revolve around the device's stability, reproducibility, and substantial equivalence to a predicate device, rather than a clinical performance study involving human subjects or expert readers for diagnostic accuracy. Therefore, many of the requested categories are not applicable to this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a typical "performance metric" vs. "threshold" format. Instead, it concludes that the device is "consistently reproducible and stable for the entire product dating" and "substantially equivalent to the predicate product." The comparison table with the predicate device implies the stability periods as key attributes demonstrating equivalence.

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

The document mentions "Four studies of CD4 Count were conducted" but does not specify the sample sizes (e.g., number of vials, number of runs, number of samples per run) for any of these studies. It also does not explicitly state the country of origin for the data or whether it was retrospective or prospective, though general product development/validation studies are typically prospective.

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

Not applicable. This device is a quality control material, not a diagnostic device that requires expert interpretation of results to establish ground truth for a test set. The "ground truth" for a control would relate to its manufacturing specifications and stability.

4. Adjudication Method for the Test Set:

Not applicable. There was no diagnostic test set requiring human adjudication.

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 device is a quality control material and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This device is a physical control material and does not involve an algorithm for diagnostic performance.

7. The Type of Ground Truth Used:

The ground truth implicitly used for this type of quality control device would be:

• Manufacturing Specifications: The inherent properties and expected values established during the manufacturing process for the control material.
• Reference Method/Predicate Device Comparison: Performance relative to a legally marketed predicate device (CD-Chex® Plus BC) and established flow cytometry methods for assessing reproducibility and stability.

8. The Sample Size for the Training Set:

Not applicable. This device is a quality control material, not a machine learning model that requires a training set.

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

Not applicable. There was no training set for a machine learning model.

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CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flow-cytometric procedures performed with Beckman Coulter® flow cytometry instruments.

CD-Chex Plus BC is a suspension of stabilized human red blood cells and human white blood cells packaged in a plastic vial containing 3.0 mL volumes. The vials are packaged in a vacuum formed "clam-shell" box.

The provided text describes a 510(k) premarket notification for a medical device called CD-Chex® Plus BC, which is an immunophenotyping control. The information focuses on demonstrating its substantial equivalence to a predicate device, CD-Chex® Plus, and its stability and reproducibility.

However, the submission does not contain the kind of detailed information requested regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, or ground truth establishment relevant to an AI/ML medical device. This is because CD-Chex® Plus BC is a quality control specimen, not an AI/ML algorithm. The "device performance" in this context refers to its stability and reproducibility as a control material, not the diagnostic performance of an AI system.

Therefore, many of the requested fields cannot be directly populated from the provided text as they are designed for evaluating AI/ML-based diagnostic devices.

Here's an attempt to answer the questions based on the available information, noting where the information is not applicable or not provided for this type of device:

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

For a quality control specimen like CD-Chex® Plus BC, "acceptance criteria" and "device performance" relate to its ability to remain stable and reproducible over time and across different sites. Specific quantifiable criteria (e.g., allowable ranges for cell counts or antigen expression) are not detailed in this summary but would typically be established by the manufacturer and validated through the studies mentioned.

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

• Test Set Sample Size: Not explicitly stated. The studies involved testing the product over time and at alternate sites, implying multiple samples of the CD-Chex® Plus BC product itself were used.
• Data Provenance: Not specified. The studies were likely conducted by the manufacturer (Streck) and potentially collaborating sites (Alternate Site Testing). It's reasonable to assume the studies were prospective, as they involved monitoring the product's stability and performance over time.

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 concept is not directly applicable to a quality control specimen. The "ground truth" for CD-Chex® Plus BC would be its inherent specifications and expected values (e.g., target ranges for cell populations or fluorescence intensities), which are established through the manufacturing process and extensive characterization/validation by the manufacturer's R&D and QA teams. This doesn't involve "experts" in the context of diagnostic interpretation.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of diagnostic data, which is not relevant for a quality control product.

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

Not applicable. MRMC studies are for evaluating the impact of an AI system on human diagnosticians. CD-Chex® Plus BC is a quality control material for flow cytometry instruments, not an AI diagnostic tool.

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

Not applicable. CD-Chex® Plus BC is not an algorithm. Its performance is evaluated intrinsically as a biological control material.

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

As explained in point 3, the "ground truth" for a quality control material is its established specifications and expected performance characteristics, determined by the manufacturer's internal validation processes and scientific principles of cellular stability. It's not based on expert consensus, pathology, or outcomes data in the diagnostic sense.

8. The sample size for the training set

Not applicable. As a quality control specimen, CD-Chex® Plus BC does not have a "training set" in the context of machine learning. The studies listed (Closed Vial Stability, Open Vial Stability, Alternate Site Testing) are validation studies of the manufactured product.

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

Not applicable. There is no "training set" and associated "ground truth" in the AI/ML sense for this product. The "truth" about the product's functionality (stability and reproducibility) is established through the experimental results of the "Testing Performed" section.

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CD Chex CD 34 is designed as a control sample for evaluating the binding of monoclonal antibody using flow cytometry. It is intended to be used with Becton Dickinson ProCount Progenitor Cell enumeration kit and with systems using ISHAGE protocol for CD 34 stem cell marker.

A clinical laboratory performing quantitative stem cell analysis needs a control specimen for verifying the measurement process. CD Chex CD 34 is such a specimen. It consists of stabilized placental blood containing a population of CD 34 positive stem cells. It is used as a procedural control for monitoring monoclonal antibody binding in flow cytometry methods. Users of Becton Dickinson ProCount Progenitor Cell Enumeration Kit or ISHAGE protocol can validate their CD 34 results by controlling the procedure with CD Chex CD 34.

CD Chex CD 34 is a stabilized suspension of human placental blood containing red blood cells and white blood cells. It is packaged in glass vials containing 1 ml of product. Closures are polyproplylene screw caps. The package contains two vials of a single concentration and an assay sheet stating the expected values.

Below is the requested information regarding the acceptance criteria and study details for the CD Chex CD 34 device:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the device performance in a qualitative manner rather than providing specific numerical acceptance criteria and corresponding performance metrics for each criterion. The study aimed to verify the product performed to specifications, but the specifications themselves are not detailed in quantitative terms.

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

• Sample Size: "Studies were conducted on three (3) Pilot lots". The exact number of individual samples (vials) within these lots tested is not specified beyond this.
• Data Provenance: Not explicitly stated, but given it is a product from Streck Laboratories, Inc. in Omaha, Nebraska, and the submission is to the FDA, it is most likely from internal laboratory testing, likely prospective. Country of origin of the data is implicitly the USA.

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 in the document. The device is a control material for evaluating monoclonal antibody binding using flow cytometry, where the "ground truth" would typically be the expected values for the CD 34 marker established by the manufacturer's internal assay and calibration methods, rather than expert consensus on individual patient samples.

4. Adjudication method for the test set:

This information is not applicable/provided. The study focuses on the stability and reproducibility of a control material against its own specifications, not on diagnostic accuracy requiring adjudication of interpretations.

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/provided. The device is an immunophenotyping control used to verify the performance of flow cytometry systems and reagents, not an AI-assisted diagnostic tool for Human-in-the-Loop interpretation.

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

This information is not applicable/provided. The device is a control material, not an algorithm. Its performance is evaluated against pre-defined specifications through laboratory testing.

7. The type of ground truth used:

The "ground truth" for this control device is its pre-determined expected values for CD 34 expression, which are established internally by the manufacturer during its assay and calibration processes. The document states, "The package contains two vials of a single concentration and an assay sheet stating the expected values." This implies that the performance was compared against these established expected values.

8. The sample size for the training set:

This information is not applicable/provided. The device is a control material, not a machine learning algorithm that requires a "training set."

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

This information is not applicable/provided. As above, the device is not an AI/ML algorithm requiring a training set. The "ground truth" for the device's expected performance (its assay values) would be established by the manufacturer's validated internal methods during product development and manufacturing.

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CD-Chex PLUS is intended to be used as a control for evaluating monoclonal antibody binding by flow cytometry. CD-Chex PLUS control cells possess surface antigens detectable with monoclonal antibodies. When these cells are stained with fluorescent antibodies and analyzed by flow cytometry they provide a reference for normal peripheral blood leukocytes. CD-Chex PLUS is designed for use on Becton Dickinson and Coulter flow cytometry systems

CD-Chex PLUS is a suspension of stablized human red blood cells and human white cells packaged in glass vials containing 2.5 or 4.0 mL volumes. Closures are polypropylene screw-top caps. The vials are packaged in polystyrene jars.

The provided 510(k) summary for K960894 (CD-Chex PLUS) does not contain sufficient detail to complete all sections of the request. This device is an immunophenotyping control, not an AI/ML powered device, therefore many of the requested categories (e.g., sample size for test set, expert qualifications, MRMC, training set details) are not applicable or not provided in the context of typical AI/ML device studies.

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

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

The document speaks generally about "reproducibility" and "stability" as key performance indicators without specifying numerical acceptance criteria for each. The stated device performance is that it met these unspecified criteria.

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 mentions "Four studies" were conducted but does not specify the sample sizes (e.g., number of lots, number of vials, number of sites) for each study. The data provenance is not specified beyond being generated by "Streck Laboratories, Inc."

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)

Not applicable. This device is a control material, not a diagnostic device that requires expert interpretation for ground truth establishment. Its performance is evaluated based on its own inherent stability and reproducibility properties when analyzed by flow cytometry systems.

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

Not applicable, as ground truth by expert consensus is not relevant for this type of device.

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 not an AI-powered device, and no human reader effectiveness study would be performed for a laboratory control.

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

Not applicable. This is not an algorithm-based device. Its performance is evaluated through laboratory studies on its physical characteristics and behavior in flow cytometry systems.

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

The concept of "ground truth" as typically defined for diagnostic or AI devices (e.g., pathology, clinical outcome) is not directly applicable here. For a control material like CD-Chex PLUS, the "truth" is established by its intrinsic and consistent characteristics (antigen expression, cell count, viability) when measured by a flow cytometer, and its ability to provide a predictable reference. The performance is assessed against expected values or by comparison to a predicate device, rather than against an independent clinical "ground truth."

8. The sample size for the training set

Not applicable. This device is a control material, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a control material, not an AI/ML algorithm that requires a training set.

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