(67 days)
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.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Long term stability | "The studies verified that the product performed to specifications" |
| Open vial stability | "The studies verified that the product performed to specifications" |
| Within-run reproducibility | "The studies verified that the product performed to specifications" |
| Site to Site reproducibility | "The studies verified that the product performed to specifications" |
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.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.