(112 days)
IMMUNO-TROL™ Control Cells (Immuno-Trol) is an for an assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytomerry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of reagent performance and the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by flow cytometry. CD populations intended "For In Vitro Diagnostic Use" and those intended "For Research Use In Diagnostic Procedures." are given in separate tables in the TABLE OF EXPECTED RESULTS section of the Immuno-Trol package insert.
Immunophenotyping analysis by flow cytometry involves the identification and enumeration of targeted cells in whole blood samples. Whole blood samples are stained with monoclonal antibodies and erythrocytes are lysed prior to flow cytometric analysis. A positive cell control is required to verify reagent performance, sample performance, sample preparation methods, and staining procedures. A positive cell control should mimic a representative whole blood sample in terms of monoclonal antibody performance, erythrocyte lysing, and flow cytometric analysis.
IMMUNO-TROL™ Control Cells (Immuno-Trol) is an assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample.
The IMMUNO-TROL™ Control Cells device is a quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It is intended to provide a positive cell control that mimics a whole blood sample to verify reagent performance, sample preparation methods, and staining procedures.
Here's a breakdown of the acceptance criteria and supporting study details:
1. Acceptance Criteria and Reported Device Performance
The general acceptance criterion across all studies was that "all values met the Acceptance Criteria." While specific numerical performance targets (e.g., specific ranges for percent positive or absolute counts) are not explicitly stated in this document for each individual parameter, the document consistently indicates successful performance against these internal criteria. The comparison to predicate devices (Normal Whole Blood (NWB) and CYTO-TROL™ Control Cells Kit (CYTO-TROL)) served as an implicit benchmark for acceptable performance.
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Vial-to-Vial Reproducibility | Consistency and reproducibility of Immuno-Trol filled vials, expressed in cells/mL. (Implicit: Values for RBC and WBC concentrations should fall within predefined acceptable ranges). | "The study results were expressed in terms of cells/mL and all values met the Acceptance Criteria. These data demonstrate the consistency and reproducibility of Immuno-Trol filled vials." |
| Lot-to-Lot Reproducibility | Consistency and reproducibility of Immuno-Trol between lots, expressed in percent positive (%) and absolute count (cells/uL) for leukocyte surface antigens. (Implicit: Values should fall within predefined acceptable ranges and demonstrate consistency across lots). | "Testing produced overall percent positive (%) and absolute count (as applicable) results for the leukocyte surface antigens given in the Immuno-Trol Package Insert. The study results were expressed in terms of percent positive (%) and absolute count (cells/uL) and all values met the Acceptance Criteria. These data demonstrate the consistency and reproducibility of Immuno-Trol between lots." |
| Stability (Closed Vial) | Immuno-Trol meets reagent and sample stability characteristics and claims for 90 days at 2-8°C, expressed in percent positive (%) and absolute count (cells/uL). (Implicit: Values should remain within predefined acceptable ranges over the specified duration and temperature). | "The study results were expressed in terms of percent positive (%) and absolute count (cells/uL) and all values met the Acceptance Criteria. These data demonstrate Immuno-Trol meets both reagent and sample stability characteristics and claims under the storage and temperature conditions studied." |
| Stability (Open Vial) | Immuno-Trol meets reagent and sample stability characteristics and claims for 30 days at 2-8°C, expressed in percent positive (%) and absolute count (cells/uL). (Implicit: Values should remain within predefined acceptable ranges over the specified duration and temperature). | "The study results were expressed in terms of percent positive (%) and absolute count (cells/uL) and all values met the Acceptance Criteria. These data demonstrate Immuno-Trol meets both reagent and sample stability characteristics and claims under the storage and temperature conditions studied." |
| Stability (Stored Prepared Sample) | Immuno-Trol meets reagent and sample stability characteristics and claims for 2 hours at 20-25°C and 24 hours at 2-8°C, expressed in percent positive (%) and absolute count (cells/uL). (Implicit: Values should remain within predefined acceptable ranges over the specified durations and temperatures). | "The study results were expressed in terms of percent positive (%) and absolute count (cells/uL) and all values met the Acceptance Criteria. These data demonstrate Immuno-Trol meets both reagent and sample stability characteristics and claims under the storage and temperature conditions studied." |
| Absolute Count Method Verification | Suitability of using the Flow-Count (Direct) Method for absolute count determination of Immuno-Trol leukocyte surface antigens. Absolute count results from Flow-Count (Direct) Method and Standard (Indirect) Method should be essentially identical and all values should meet acceptance criteria. (Implicit: Values should fall within predefined acceptable ranges and show equivalence between methods). | "The study results were expressed in terms of percent positive (%) and absolute count (cells/uL) and all values met the Acceptance Criteria. In addition, both the Flow-Count (Direct) Method and the Standard (Indirect) Method provided essentially identical absolute count results for Immuno-Trol and NWB. These data clearly demonstrate the suitability of using the Flow-Count (Direct) Method for absolute count determination of Immuno-Trol leukocyte surface antigens." |
| Assay Precision | Reproducibility of Immuno-Trol performance, with individual and combined assay precision for various study parameters meeting acceptance criteria. Performance should be comparable to NWB and CYTO-TROL with minimal variation (means, standard deviations, and coefficients of variation). (Implicit: Values should fall within predefined acceptable ranges and demonstrate similar precision to predicate devices). | "All values met the Acceptance Criteria. In addition, Immuno-Trol, NWB and CYTO-TROL varied little as evidenced by the means, standard deviations and coefficients of variation for the different sets of measurements. These data demonstrate Immuno-Trol performs in a manner comparable to the Predicate System components, NWB and CYTO-TROL." |
Study Details
The provided document describes various studies conducted to assess the performance of IMMUNO-TROL™ Control Cells.
2. Sample Size Used for the Test Set and Data Provenance
- Vial-to-Vial Reproducibility: "The filled vials were sampled from Immuno-Trol lots at regular intervals across the fill." (Specific number of vials/samples, country of origin, and whether retrospective/prospective are not explicitly provided. However, the description implies prospective testing of manufactured lots.)
- Lot-to-Lot Reproducibility: "Testing produced overall percent positive (%) and absolute count (as applicable) results for the leukocyte surface antigens given in the Immuno-Trol Package Insert." (Specific number of lots, different instrument-operator combinations, country of origin, and whether retrospective/prospective are not explicitly provided. Implies prospective testing.)
- Stability Studies: Two study protocols were used: "Closed Vial: 90 days at 2-8℃; Open Vial: 30 days at 2-8℃" and "Stored Prepared Sample: 2 hours at 20-25°C; 24 hours at 2-8°C." "Immuno-Trol was tested using one-color, threecolor and four-color monoclonal antibody reagents under the different storage and temperature conditions over test periods extending up to and beyond the respective 90-day and 30-day claims." (Specific number of samples/lots, country of origin, and whether retrospective/prospective are not explicitly provided. Implies prospective testing over time.)
- Absolute Count Method Verification: "Immuno-Trol" and "NWB was also tested under the same conditions." (Specific number of samples and country of origin are not explicitly provided. Implies prospective testing.)
- Assay Precision: "Immuno-Trol on different instrument-operator combinations and over multiple test days using one-color and four-color and four-color monoclonal antibody reagents. NWB and CYTO-TROL were also tested under the same conditions." (Specific number of samples, test days, country of origin, and whether retrospective/prospective are not explicitly provided. Implies prospective testing.)
Overall Data Provenance: The company, Coulter Corporation, is based in Miami, Florida, USA. Therefore, it is highly likely the data provenance is USA. The studies are described as "Product testing to assess the performance," implying they are prospective studies conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The concept of "ground truth" as typically applied to AI/diagnostic imaging (e.g., expert consensus) is not applicable here. This document describes the performance of a quality control material intended to verify the performance of other diagnostic reagents and methods, not to provide a diagnosis itself. The "ground truth" for this device is its inherent, manufactured cellular composition and expected reactivity with specific antibody reagents, which are compared against established performance specifications.
4. Adjudication Method for the Test Set
Not applicable. As this is a performance study for a quality control material, not a clinical diagnostic device requiring expert interpretation of results, there is no adjudication method in the traditional sense (e.g., 2+1, 3+1). The "ground truth" is defined by the product's design and manufacturing specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or algorithms where human readers interpret cases. The IMMUNO-TROL device is a quality control material.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The IMMUNO-TROL is a physical control cell product, not an algorithm. Its performance is intrinsically linked to its use with flow cytometry instruments and monoclonal antibody reagents.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of IMMUNO-TROL is based on established manufacturing specifications and expected reactivity of the control cells with monoclonal antibody reagents for immunophenotyping. This constitutes an analytical truth rather than a clinical ground truth like pathology or outcome data. The "Acceptance Criteria" mentioned throughout the document are derived from these internal specifications. The predicate devices (NWB and CYTO-TROL) also served as a comparative benchmark to ensure comparable performance.
8. Sample Size for the Training Set
Not applicable. The IMMUNO-TROL is not an artificial intelligence or machine learning device that requires a "training set." It is a manufactured quality control product.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this product.
§ 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.