(296 days)
XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:
RBC(106/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F*(103/μL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/uL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103/pL), LYMPH#(103/pL), MONO# (103/pL), BASO#(103/pL), IG#(103/ μL), IPF(%), IPF# (103/pL), RET#(106/μL), RET%, IRF%, RET-HE(pg), NRBC#* (100 WBC)
*Not Available on the XN-L.
XN CHECK™ is a three level hematology control the following: stabilized red blood cell component(s), stabilized white blood cell component(s) stabilized platelet component(s), and stablic on onnonent(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps with a 3 mL fill. The vials will be pacum formed clamshell container with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.
The provided text is a 510(k) Summary for the XN CHECK™ hematology quality control mixture. It details the device's intended use, comparison to a predicate device, and conclusions from tests. However, it does not fully elaborate on the detailed acceptance criteria for each claimed parameter or explicitly describe the "study that proves the device meets the acceptance criteria" in terms of specific statistical analyses, sample sizes for test sets with ground truth, expert qualifications, or multi-reader studies.
Therefore, many of the requested details cannot be extracted directly from this document. The information provided is at a high level, focusing on demonstrating substantial equivalence to a predicate device.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "XN CHECK is used for control and calibration verification... and that the product is stable for the entire product dating." It also mentions "reproducible" and "stable" in the conclusions. However, it does not provide specific numerical acceptance criteria (e.g., maximum allowable coefficient of variation for precision, or specific stability limits for each parameter) nor quantified performance data for each of the numerous assayed parameters. It only describes the types of studies conducted.
| Parameter Category | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Implied as met, but not quantified) |
|---|---|---|
| Precision | (e.g., CV% |
§ 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.