(25 days)
StatusFlow" is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, RBC lysis, instrument set-up, instrument performance and data analysis.
The product is an assay control mixture for flow cytometric determinations of leukocyte subsets present in whole blood samples. StatusFlow "" is composed of human leukocytes and erythrocytes in a stabilizing medium.
The provided document is a 510(k) summary for the StatusFlow CD4 Low Whole Blood Process Control for Flow Cytometry, a device manufactured by R&D Systems, Inc. It describes the device, its intended use, and substantial equivalence to a predicate device. It also briefly mentions nonclinical testing performed. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria values, a detailed study description, sample sizes for test and training sets, or expert qualifications and adjudication methods as would be found in a comprehensive study report.
Based on the available information, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (as reported) | Reported Device Performance (as reported) |
|---|---|---|
| Stability | Remaining within the assay range over the life of the product. | StatusFlow 40 passed this criterion. Expiration dating established at 30 days closed vial and 9 days (or 9 thermal cycles) open vial when stored at 2-8°C and handled according to instructions. |
| Precision | Not explicitly stated as a numerical criterion, but implied to be "small standard deviations and low %CVs." | Demonstrated by small standard deviations and low %CVs obtained during testing. |
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided document.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing is described as "Nonclinical testing," which typically means laboratory-based testing rather than clinical patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable or not specified. This device is a process control for immunophenotyping, not a diagnostic device that requires expert interpretation of results to establish ground truth for testing. The "ground truth" for a control would be its known component concentrations or characteristics, established through manufacturing and established analytical methods.
- Qualifications of Experts: Not applicable or not specified.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable or not specified. Since it's a process control, the "ground truth" (or target values) would be determined by the manufacturing process and quality control, not by expert adjudication of observational data.
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:
- MRMC Study: No. This device is a process control for flow cytometry, not an AI-assisted diagnostic tool. An MRMC study is therefore not relevant.
- Effect Size of Human Readers with/without AI: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a laboratory reagent/control, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for a process control like StatusFlow would be analytical reference values established during its manufacturing and characterization (e.g., known concentrations/percentages of leukocyte subsets). These values would be determined through validated laboratory methods, not expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable or not specified. As a process control, the development likely involves extensive R&D and optimization, but the concept of a "training set" in the context of machine learning or AI does not apply here. The document details "nonclinical testing" related to stability and precision, implying laboratory studies to characterize the product's performance.
9. How the ground truth for the training set was established:
- How Ground Truth Established (Training Set): Not applicable. The "ground truth" for the development and testing of such a control would be the controlled manufacturing process and validated analytical methods used to characterize the product's components and expected performance.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”