(23 days)
IMMUNO-TROL™ Low Cells 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. This allows verification of reagent performance, and the methods used for staining of targeted cells, lysing erythrocytes, and analyzing samples by flow cytometry. The product is intended "For In Vitro Diagnostic Use."
IMMUNO-TROL™ Low Cells is a liquid preparation of stabilized erythrocytes and leukocytes in a stabilizing solution containing BSA.
The provided text is a 510(k) summary for the IMMUNO-TROL™ Low Cells device. It states that the device is "substantially equivalent" to a predicate device and provides performance data primarily related to stability. However, the document does not contain specific acceptance criteria or an explicit study describing how the device quantitatively meets those criteria in terms of accuracy, precision, or other performance metrics for immunophenotyping.
The summary is primarily focused on demonstrating equivalence to an existing device (IMMUNO-TROL™ Cells) with the only noted difference being a "reduced level of CD4". The "Summary of Performance Data" section merely states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution. Stability studies of IMMUNO-TROL™ Low Cells support the Beckman Coulter stability claims of 90 days (open vial) and 9 months (closed vial)."
Therefore, I cannot provide a table of acceptance criteria and reported device performance as this information is not present in the provided document. The other requested information (sample size, experts for ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set) is also not detailed in this 510(k) summary document, as such detailed study breakdowns are not typically included in these summaries but would be part of the full 510(k) submission.
§ 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.