(42 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reproducibility | "consistently reproducible" |
| Stability for entire product dating (Closed Vial) | "stable for the entire product dating" (specifically, 60 days) |
| Stability for entire product dating (Open Vial) | "stable for the entire product dating" (specifically, 30 days) |
| Substantial Equivalence to Predicate (CD-Chex® Plus BC) | "substantially equivalent to the predicate product" |
| Intended Use Fulfillment | "fulfills its intended use when used as instructed in the product package insert" |
| Open Vial Stability (compared to predicate, 30 days) | Same (30 days) |
| Closed Vial Stability (compared to predicate, 90 days) | 60 days (Note: This is shorter than the predicate, but deemed acceptable for product dating) |
| Reagents | Same (stabilized human blood in preservative medium) |
| Storage Conditions | Same (2 - 10°C) |
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.
§ 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.