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nRBC-Chex for ADVIA® is an assayed whole blood control designed to evaluate the accuracy and precision of the Siemens Healthcare Diagnostics Inc. hematology analyzers in the measurement of the nucleated red blood cell parameter. Refer to product assay sheet.

nRBC-Chex for ADVIA® is stabilized suspension of human and animal blood, in a solution containing biological salts and anti-microbial preservatives. The product is packaged in plastic vials containing 4ml. The closures are polypropylene screw caps with polyethylene liners. There are two different levels. Level 1 has a low count and Level 2 has a higher count. The vials will be packaged in a two (2) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10°C.

The provided text describes a 510(k) summary for the device "nRBC-Chex for ADVIA®," an assayed hematology control. It details the device's intended use, comparison to a predicate device, and the studies conducted to establish its performance.

Here's an analysis of the acceptance criteria and study information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the "Conclusions Drawn From Tests," and the reported performance is from the "Discussion of Tests and Test Results." Since specific numerical criteria (e.g., "± 5% reproducibility") are not explicitly stated, the acceptance is inferred from the affirmative statements about the device's performance meeting claims.

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

The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). The studies mentioned (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, Site to Site recovery of values) would typically involve multiple runs and vials, but the specific numbers are not provided.

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

Since this device is an assayed hematology control, "ground truth" is established through measurements by calibrated analytical instruments, rather than human expert opinion. The document does not mention the involvement of human experts for establishing ground truth for the performance studies.

4. Adjudication Method for the Test Set

Not applicable. As a quality control material, the performance is assessed against established measurement principles and instrumental accuracy, not through human adjudication of diagnostic outcomes.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation devices where human readers are involved. This device is a quality control material for automated hematology analyzers, so expert interpretation of cases is not relevant.

6. If a Standalone Study Was Done

Yes, the described studies (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values) represent standalone performance evaluations of the nRBC-Chex for ADVIA® device itself, in conjunction with the specified hematology analyzers. The goal was to demonstrate its intrinsic performance as a control material. There is no mention of human-in-the-loop performance being evaluated.

7. The Type of Ground Truth Used

The ground truth for evaluating the performance of "nRBC-Chex for ADVIA®" would be based on instrumental measurements and reference methods. As an assayed hematology control, its values are established by careful measurement on reference analyzers or by comparing to reference materials, ensuring accuracy and precision. The document states it's "designed to evaluate the accuracy and precision" of hematology analyzers, implying its own values are established precisely.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is a consumable quality control material, and its development would involve formulation and testing, not a machine learning training phase.

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

Not applicable, as there is no "training set" in the context of device development described here. The ground truth for the assayed values of the control material itself would be established through extensive laboratory testing, calibration, and validation using reference methods and highly accurate analyzers.

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nRBC-Chex for LH is an assayed whole blood control designed to evaluate the accuracy and precision of the Beckman Coulter® LH 750 in its measurement of the nucleated red blood cell parameter.

nRBC-Chex for LH is stabilized suspension of human and animal blood, in a solution containing biological salts and anti-microbial preservatives. The product is packaged in plastic vials containing 4ml. The closures are polypropylene screw caps with polyethylene liners. There are two different levels. Level 1 has a low count and Level 2 has a higher count. The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package in a sk (v) product must be stored at 2 - 10°C.

The provided text describes a medical device called "nRBC-Chex for LH," which is an assayed whole blood control. The document focuses on establishing the substantial equivalence of this device to a predicate device for its intended use, rather than detailing specific acceptance criteria for a novel diagnostic algorithm's performance in a clinical study.

Therefore, many of the requested sections about acceptance criteria, sample sizes for test sets, expert involvement, and ground truth establishment, which typically apply to studies evaluating the performance of a diagnostic device (like an AI algorithm), are not directly applicable or explicitly stated in this 510(k) summary for a quality control material.

However, I can extract information related to the studies conducted to establish the performance and stability of the nRBC-Chex for LH control material.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria in the way one would for a diagnostic test's sensitivity/specificity. Instead, it describes general claims and confirms stability and reproducibility.

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

• Test Set Size: Not explicitly stated. The document mentions "Four types of studies were conducted," but details on the number of samples, runs, or lots used in each study (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values) are not provided.
• Data Provenance: Not specified. There is no mention of the country of origin or whether the studies were retrospective or prospective. Given the nature of a quality control material, the studies would likely be prospective laboratory experiments conducted by the manufacturer.

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

• This is not applicable as the device is a control material, not a diagnostic device requiring expert interpretation of clinical data for ground truth establishment. The "ground truth" for a control material would be its manufactured, assayed values, determined by standardized laboratory methods, not by expert consensus on clinical cases.

4. Adjudication method for the test set:

• Not applicable. This device is a control material, and its performance is evaluated against defined parameters, not through adjudication of clinical cases.

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 diagnostic device, nor does it involve human readers interpreting cases. It is a quality control material for a hematology analyzer.

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

• Not applicable. This is a physical control material, not an algorithm. Its "standalone" performance refers to its intrinsic stability and reproducibility when measured by the target instrument (Beckman Coulter LH 750). The studies conducted (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values) can be considered evaluations of its standalone performance as a control material.

7. The type of ground truth used:

• For a control material like nRBC-Chex for LH, the "ground truth" refers to the assigned target values for the nucleated red blood cell parameter. These values would be established during the manufacturing and assaying process, typically through highly precise and accurate reference methods. The document doesn't explicitly detail how these specific target values are established but implies they are part of the "assayed" nature of the control.

8. The sample size for the training set:

• Not applicable. This is a physical control material, not a machine learning algorithm that requires a training set.

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

• Not applicable. No training set is involved.

Ask a specific question about this device

Ask a specific question about this device