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It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. The CBC-5D Plus Retics Hematology Control is designed to document and monitor values obtained from Coulter® hematology instruments. For in vitro Diagnostic Use Only

CBC-5D Plus Retics is an in vitro diagnostic control composed of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of monitoring the performance of Coulter® hematology analyzers. It is sampled in the same manner as a patient specimen.

The CBC-5D Plus Retics Hematology Control is an in vitro diagnostic control device. The provided text outlines the acceptance criteria and the study conducted to demonstrate the device's performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The study utilized "3 validation lots" of the CBC-5D Plus Retics Hematology Control.
• Data Provenance: Not explicitly stated, but the testing was conducted in a "laboratory setting." The K number (K072096) indicates a premarket notification for a new device, suggesting the data is prospective, generated specifically for this submission. The manufacturer is R&D Systems, Inc., located in Minneapolis, MN, USA, implying the data likely originated from the USA.

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

This device is a hematology control, not a diagnostic device that requires expert interpretation of images or clinical data. Therefore, the concept of "experts used to establish ground truth" as typically applied to imaging or clinical decision support AI is not relevant here. The 'ground truth' for a control device is its expected analytical range and stability.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or complex disease diagnosis to resolve discrepancies. This is not applicable to an analytical control device where performance is measured against established analytical methods and specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study investigates the impact of a device (often AI) on human reader performance for diagnostic tasks, which is not applicable to a hematology control device.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

While the device's performance was evaluated independently, the term "standalone" in the context of an algorithm's performance without human intervention is not fully applicable. This device is a control material used by humans to monitor instruments. The performance described (precision, stability) is inherent to the control material itself, rather than an algorithm's output.

7. The Type of Ground Truth Used

The ground truth for this hematology control device is its established analytical range and stability specifications. The device's performance was measured against these predefined criteria, which are derived from the chemical and biological properties of the control and its interaction with hematology analyzers. The goal was to demonstrate that it remained within the assay range over the life of the product.

8. The Sample Size for the Training Set

The concept of a "training set" is not relevant for this medical device. The CBC-5D Plus Retics Hematology Control is a physical control material, not an AI/ML algorithm that requires training data. Its performance is validated through laboratory testing of manufactured lots.

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

As there is no training set for this device, this question is not applicable.

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